What Jobs are available for Clinical Coordinator in Malaysia?
Showing 19 Clinical Coordinator jobs in Malaysia
Clinical Research Associate
Petaling Jaya, Selangor
Merck Gruppe - MSD Sharp & Dohme
Posted today
Job Viewed
Job Description
Job Description Clinical Research Associate (CRA) • Based in Malaysia, named one of the
Best Companies to Work for in 2019
by HR Asia • We were awarded
‘Sponsor of the Year’
in 2019, 2020, 2022 and 2024 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the country! • We have a proud legacy of turning breakthrough science into medicines and vaccines that save and improve lives around the world. We are focused on discovering new solutions for today and the future! • Join the premier biopharmaceutical company that has been in the business for more than
125 years The role is accountable for performance and compliance for assigned protocols and sites in a country.
Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.
Responsibilities include, but are not limited to:
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs clinical study site
management/monitoring
activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gains an in-depth understanding of the study protocol and related procedures. • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. • Participates & provides inputs on site selection and validation activities. • Performs remote and on-site monitoring & oversight activities using various tools to ensure: o Data generated at site are complete, accurate and unbiased. o Subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed. • Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as
appropriate/required. • Supports and/or leads audit/inspection activities as needed. • Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. • Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.
Extent of Travel:
• Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling 2-3 days/week. • Current driver’s license preferred (Must have in certain countries). Qualifications, Skills & Experience CORE Competency Expectations: • Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. • Hands on knowledge of Good Documentation Practices. • Proven Skills in Site Management including management of site performance and patient recruitment. • Demonstrated high level of monitoring skill with independent professional judgment. • Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. • Ability to understand and analyse data/metrics and act appropriately. • Capable of managing complex issues, works in a solution-oriented manner. • Performs root cause analysis and implements preventative and corrective action. Behavioural Competency Expectations: • Effective time management, organizational and interpersonal skills, conflict management, problem solving skills. • Able to work highly independently across multiple protocols, sites and therapy areas. • High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. • Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. • Demonstrates commitment to Customer focus. • Works with high quality and compliance mind-set. • Positive mindset, growth mindset, capable of working independently and being self-driven. • Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices. Experience Requirements: Required: • Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO. Educational Requirements: Preferred: • B.A./B.S. with strong emphasis in science and/or biology. What we look for … Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply
HERE Current Contingent Workers apply
HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular
Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid
Shift: Valid Driving License: Hazardous Material(s): Required Skills: Accountability, Accountability, Adaptability, Adverse Event Reporting System, Biopharmaceutical Industry, Biopharmaceuticals, Clinical Medicine, Clinical Research Methods, Clinical Sciences, Clinical Site Management, Clinical Study Management, Clinical Testing, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Reporting, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Healthcare Innovation, Management Process, Medical Research, Monitoring Control, Organizational Performance Management, Problem Solving, Protocol Adherence {+ 4 more}
Preferred Skills: Job Posting End Date: 07/15/2025
*A job posting is effective until 11:59:59PM on the day
BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day
BEFORE
the job posting end date.
Requisition ID: R
#J-18808-Ljbffr
Best Companies to Work for in 2019
by HR Asia • We were awarded
‘Sponsor of the Year’
in 2019, 2020, 2022 and 2024 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the country! • We have a proud legacy of turning breakthrough science into medicines and vaccines that save and improve lives around the world. We are focused on discovering new solutions for today and the future! • Join the premier biopharmaceutical company that has been in the business for more than
125 years The role is accountable for performance and compliance for assigned protocols and sites in a country.
Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems.
Responsibilities include, but are not limited to:
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. • Performs clinical study site
management/monitoring
activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. • Gains an in-depth understanding of the study protocol and related procedures. • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. • Participates & provides inputs on site selection and validation activities. • Performs remote and on-site monitoring & oversight activities using various tools to ensure: o Data generated at site are complete, accurate and unbiased. o Subjects’ right, safety and well-being are protected. • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. • Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed. • Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. • Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as
appropriate/required. • Supports and/or leads audit/inspection activities as needed. • Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. • Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.
Extent of Travel:
• Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling 2-3 days/week. • Current driver’s license preferred (Must have in certain countries). Qualifications, Skills & Experience CORE Competency Expectations: • Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. • Hands on knowledge of Good Documentation Practices. • Proven Skills in Site Management including management of site performance and patient recruitment. • Demonstrated high level of monitoring skill with independent professional judgment. • Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. • Ability to understand and analyse data/metrics and act appropriately. • Capable of managing complex issues, works in a solution-oriented manner. • Performs root cause analysis and implements preventative and corrective action. Behavioural Competency Expectations: • Effective time management, organizational and interpersonal skills, conflict management, problem solving skills. • Able to work highly independently across multiple protocols, sites and therapy areas. • High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. • Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. • Demonstrates commitment to Customer focus. • Works with high quality and compliance mind-set. • Positive mindset, growth mindset, capable of working independently and being self-driven. • Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices. Experience Requirements: Required: • Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO. Educational Requirements: Preferred: • B.A./B.S. with strong emphasis in science and/or biology. What we look for … Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply
HERE Current Contingent Workers apply
HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular
Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid
Shift: Valid Driving License: Hazardous Material(s): Required Skills: Accountability, Accountability, Adaptability, Adverse Event Reporting System, Biopharmaceutical Industry, Biopharmaceuticals, Clinical Medicine, Clinical Research Methods, Clinical Sciences, Clinical Site Management, Clinical Study Management, Clinical Testing, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Reporting, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Healthcare Innovation, Management Process, Medical Research, Monitoring Control, Organizational Performance Management, Problem Solving, Protocol Adherence {+ 4 more}
Preferred Skills: Job Posting End Date: 07/15/2025
*A job posting is effective until 11:59:59PM on the day
BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day
BEFORE
the job posting end date.
Requisition ID: R
#J-18808-Ljbffr
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This advertiser has chosen not to accept applicants from your region.
0
Clinical Research Associate
Petaling Jaya, Selangor
Merck
Posted today
Job Viewed
Job Description
Job Description Clinical Research Associate (CRA) Based in Malaysia, named one of the
Best Companies to Work for in 2019
by HR Asia We were awarded
‘Sponsor of the Year’
in 2019, 2020, 2022 and 2024 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the country. We have a proud legacy of turning breakthrough science into medicines and vaccines that save and improve lives around the world. We are focused on discovering new solutions for today and the future. Join the premier biopharmaceutical company that has been in the business for more than
125 years The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems. Responsibilities include, but are not limited to: Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and related procedures. Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. Participates & provides inputs on site selection and validation activities. Performs remote and on-site monitoring & oversight activities using various tools to ensure:
Data generated at site are complete, accurate and unbiased. Subjects’ right, safety and well-being are protected.
Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed. Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. Supports and/or leads audit/inspection activities as needed. Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate. Extent of Travel: Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week. Current driver’s license preferred (Must have in certain countries). Qualifications, Skills & Experience CORE Competency Expectations: Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. Hands on knowledge of Good Documentation Practices. Proven Skills in Site Management including management of site performance and patient recruitment. Demonstrated high level of monitoring skill with independent professional judgment. Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. Ability to understand and analyse data/metrics and act appropriately. Capable of managing complex issues, works in a solution-oriented manner. Performs root cause analysis and implements preventative and corrective action. Behavioural Competency Expectations: Effective time management, organizational and interpersonal skills, conflict management, problem solving skills. Able to work highly independently across multiple protocols, sites and therapy areas. High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. Demonstrates commitment to Customer focus. Works with high quality and compliance mind-set. Positive mindset, growth mindset, capable of working independently and being self-driven. Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices. Experience Requirements: Required: Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO. Educational Requirements: Preferred: B.A./B.S. with strong emphasis in science and/or biology. Merck & Co., Inc. is an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
#J-18808-Ljbffr
Best Companies to Work for in 2019
by HR Asia We were awarded
‘Sponsor of the Year’
in 2019, 2020, 2022 and 2024 from Clinical Research Malaysia for the highest number of studies and total study value recorded in the country. We have a proud legacy of turning breakthrough science into medicines and vaccines that save and improve lives around the world. We are focused on discovering new solutions for today and the future. Join the premier biopharmaceutical company that has been in the business for more than
125 years The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in internal meetings and workstreams as SME for monitoring processes and systems. Responsibilities include, but are not limited to: Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and related procedures. Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. Participates & provides inputs on site selection and validation activities. Performs remote and on-site monitoring & oversight activities using various tools to ensure:
Data generated at site are complete, accurate and unbiased. Subjects’ right, safety and well-being are protected.
Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed. Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites. Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines. Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. Supports and/or leads audit/inspection activities as needed. Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities. Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate. Extent of Travel: Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week. Current driver’s license preferred (Must have in certain countries). Qualifications, Skills & Experience CORE Competency Expectations: Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively. Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines. Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines. Hands on knowledge of Good Documentation Practices. Proven Skills in Site Management including management of site performance and patient recruitment. Demonstrated high level of monitoring skill with independent professional judgment. Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices. Ability to understand and analyse data/metrics and act appropriately. Capable of managing complex issues, works in a solution-oriented manner. Performs root cause analysis and implements preventative and corrective action. Behavioural Competency Expectations: Effective time management, organizational and interpersonal skills, conflict management, problem solving skills. Able to work highly independently across multiple protocols, sites and therapy areas. High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment. Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships. Demonstrates commitment to Customer focus. Works with high quality and compliance mind-set. Positive mindset, growth mindset, capable of working independently and being self-driven. Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices. Experience Requirements: Required: Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO. Educational Requirements: Preferred: B.A./B.S. with strong emphasis in science and/or biology. Merck & Co., Inc. is an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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1
Clinical Research Associate
George Town
Dexcom
Posted 2 days ago
Job Viewed
Job Description
Essential Duties and Responsibilities Clinical Function Ensure the smooth and efficient day‑to‑day operation of clinical trials.
Schedule and manage subject visits, including unscheduled visits, as per protocol requirements.
Recruit, consent, screen, instruct, and coordinate research subjects.
Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Dexcom’s SOPs.
Identify and escalated safety events and major protocol deviations.
Assist with assessing trends for safety and protocol deviations and communicate findings to the PI. Propose and implement corrective and preventative actions.
Trial Planning and Coordination Provide documents and information for Ethics Committee applications.
Perform tasks as delegated by the Principal Investigator in accordance with the protocol, SOPs, and applicable guidelines.
Assist in finding potential subjects through pre‑screening activities.
Prepare supplies and account for devices required for clinical studies.
Set up IT equipment for studies.
Develop clinical study materials (including, but not limited to, source documentation, IRB submissions, training slides, etc.).
Data Collection and Management Ensure timely and accurate completion of Case Report Forms (CRF/e‑CRF) and resolve queries.
Maintain essential study documents/files and make records available for review, including device accountability tracking.
Keep an ongoing record and assessment of adverse events (AEs) and serious adverse events (SAEs).
Assist with departmental audits of clinical studies and procedures.
Compliance and Ethics Ensure trial practices reflect ethical and legal standards for clinical trials.
Adhere to all Dexcom SOPs, ISO 14155:2020, and Malaysian Guideline for Good Clinical Practice.
Notify the Ethics Committee of SAEs and protocol deviations (PDs).
Prepare the site for monitoring, audit, and inspection, and implement recommended corrective actions.
Administrative Support Observe the progress of trial activities and communicate schedules/required procedures to the team.
Assist with dispensing participants’ compensation (if applicable).
Coordinate trial close‑out activities, including device investigation or disposal and archiving materials.
Involve in and contribute to all quality improvement activities of the department.
Collaborate with global Clinical PMO and study teams to establish and maintain study timelines.
Communicate effectively and professionally with coworkers, leadership, and study subjects.
Collaborate effectively with peers and leadership across departments and professionally interact/build relationships with FDA, IRB, and key opinion leaders.
Perform other duties as assigned under minimal supervision.
Required Qualifications Degree in nursing, sciences, or pharmacy. MBBS/MD with clinical experience will also be considered.
2‑5 years relevant working experience in clinical research.
Possess GCP Certification.
Proficient with MS Office Suite.
Excellent communication skills and ability to work effectively with multiple global functions.
Strong organizational skills and ability to manage competing priorities.
Strong critical thinking and independence.
Willing to work, hands‑on, in an extremely fast‑paced environment with high attention to details and accuracy.
Preferred Qualifications Experience in continuous glucose monitoring (CGM) or diabetes‑related studies.
Experience working closely with a global team.
Experience with Clinical Trial Management Systems (e.g. Veeva).
Application Questions
How many years' experience do you have as a clinical research associate (CRA)?
Which of the following statements best describes your right to work in Malaysia?
What's your expected monthly basic salary?
Which of the following types of qualifications do you have?
How many years' experience do you have as a Clinical Research Coordinator?
#J-18808-Ljbffr
Schedule and manage subject visits, including unscheduled visits, as per protocol requirements.
Recruit, consent, screen, instruct, and coordinate research subjects.
Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Dexcom’s SOPs.
Identify and escalated safety events and major protocol deviations.
Assist with assessing trends for safety and protocol deviations and communicate findings to the PI. Propose and implement corrective and preventative actions.
Trial Planning and Coordination Provide documents and information for Ethics Committee applications.
Perform tasks as delegated by the Principal Investigator in accordance with the protocol, SOPs, and applicable guidelines.
Assist in finding potential subjects through pre‑screening activities.
Prepare supplies and account for devices required for clinical studies.
Set up IT equipment for studies.
Develop clinical study materials (including, but not limited to, source documentation, IRB submissions, training slides, etc.).
Data Collection and Management Ensure timely and accurate completion of Case Report Forms (CRF/e‑CRF) and resolve queries.
Maintain essential study documents/files and make records available for review, including device accountability tracking.
Keep an ongoing record and assessment of adverse events (AEs) and serious adverse events (SAEs).
Assist with departmental audits of clinical studies and procedures.
Compliance and Ethics Ensure trial practices reflect ethical and legal standards for clinical trials.
Adhere to all Dexcom SOPs, ISO 14155:2020, and Malaysian Guideline for Good Clinical Practice.
Notify the Ethics Committee of SAEs and protocol deviations (PDs).
Prepare the site for monitoring, audit, and inspection, and implement recommended corrective actions.
Administrative Support Observe the progress of trial activities and communicate schedules/required procedures to the team.
Assist with dispensing participants’ compensation (if applicable).
Coordinate trial close‑out activities, including device investigation or disposal and archiving materials.
Involve in and contribute to all quality improvement activities of the department.
Collaborate with global Clinical PMO and study teams to establish and maintain study timelines.
Communicate effectively and professionally with coworkers, leadership, and study subjects.
Collaborate effectively with peers and leadership across departments and professionally interact/build relationships with FDA, IRB, and key opinion leaders.
Perform other duties as assigned under minimal supervision.
Required Qualifications Degree in nursing, sciences, or pharmacy. MBBS/MD with clinical experience will also be considered.
2‑5 years relevant working experience in clinical research.
Possess GCP Certification.
Proficient with MS Office Suite.
Excellent communication skills and ability to work effectively with multiple global functions.
Strong organizational skills and ability to manage competing priorities.
Strong critical thinking and independence.
Willing to work, hands‑on, in an extremely fast‑paced environment with high attention to details and accuracy.
Preferred Qualifications Experience in continuous glucose monitoring (CGM) or diabetes‑related studies.
Experience working closely with a global team.
Experience with Clinical Trial Management Systems (e.g. Veeva).
Application Questions
How many years' experience do you have as a clinical research associate (CRA)?
Which of the following statements best describes your right to work in Malaysia?
What's your expected monthly basic salary?
Which of the following types of qualifications do you have?
How many years' experience do you have as a Clinical Research Coordinator?
#J-18808-Ljbffr
Is this job a match or a miss?
This advertiser has chosen not to accept applicants from your region.
2
Clinical Research Associate
George Town
Dexcom
Posted 2 days ago
Job Viewed
Job Description
Clinical Research Associate Join to apply for the
Clinical Research Associate
role at
Dexcom .
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we’re just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we’ve started: Improving human health.
Position Summary Join our dynamic and growing global team as a Study Coordinator (SC), where you’ll play a pivotal role in the conduct of clinical trials. You’ll be responsible for a variety of activities essential to the success of these trials, including trial start‑up activities, ongoing study management, and coordination of trial subjects at every stage of their clinical trial journey. As the main point of contact for trial subjects, you’ll work closely with the Principal Investigator (PI) to ensure the safety of patients and the integrity of data collected, in accordance with study protocol requirements, Good Clinical Practice (GCP), and applicable regulatory requirements.
Essential Duties and Responsibilities
Ensure the smooth and efficient day‑to‑day operation of clinical trials.
Schedule and manage subject visits, including unscheduled visits, as per protocol requirements.
Recruit, consent, screen, instruct, and coordinate research subjects.
Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Dexcom’s SOPs.
Identify and elevate safety events and major protocol deviations.
Assist with assessing trends for safety and protocol deviations and communicate findings to the PI. Propose and implement corrective and preventative actions.
Trial Planning and Coordination
Provide documents and information for Ethics Committee applications.
Perform tasks as delegated by the PI in accordance with the protocol, SOPs, and applicable guidelines.
Assist in finding potential subjects through pre‑screening activities.
Prepare supplies and account for devices required for clinical studies.
Set up IT equipment for studies.
Develop clinical study materials (including, but not limited to, source documentation, IRB submissions, training slides, etc.).
Data Collection and Management
Ensure timely and accurate completion of Case Report Forms (CRF/e‑CRF) and resolve queries.
Maintain essential study documents/files and make records available for review, including but not limited to device accountability tracking.
Keep an ongoing record and assessment of adverse events (AEs) and serious adverse events (SAEs).
Assist with departmental audits of clinical studies and procedures.
Compliance and Ethics
Ensure trial practices reflect ethical and legal standards for clinical trials.
Adhere to all Dexcom SOPs, ISO 14155:2020, and Malaysian Guideline for Good Clinical Practice.
Notify the Ethics Committee of SAEs and protocol deviations.
Prepare the site for monitoring, audit, and inspection, and implement recommended corrective actions.
Administrative Support
Observe the progress of trial activities and communicate schedules/required procedures to the team.
Assist with dispensing participants’ compensation (if applicable).
Coordinate trial close‑out activities, including device investigation or disposal and archiving materials.
Involve in and contribute to all quality improvement activities of the department.
Collaborate with global Clinical PMO and study teams to establish and maintain study timelines.
Communicate effectively and professionally with coworkers, leadership, and study subjects.
Collaborate effectively with peers and leadership across departments and professionally interact/build relationships with FDA, IRB, and key opinion leaders.
Perform other duties as assigned under minimal supervision.
Required Qualifications
Degree in nursing, sciences, or pharmacy; MBBS/MD with clinical experience will also be considered.
2‑5 years relevant working experience in clinical research.
Possess GCP Certification.
Proficient with MS Office Suite.
Excellent communication skills and ability to work effectively with multiple global functions.
Strong organizational skills and ability to manage competing priorities.
Strong critical thinking and independence.
Willing to work hands‑on in an extremely fast‑paced environment with high attention to detail and accuracy.
Preferred Qualifications
Experience in continuous glucose monitoring (CGM) or diabetes‑related studies.
Experience working closely with a global team.
Experience with Clinical Trial Management Systems (e.g., Veeva).
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees, or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
Seniority Level Not Applicable
Employment Type Full‑time
Job Function Research, Analyst, and Information Technology
Industry Medical Equipment Manufacturing
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Clinical Research Associate
role at
Dexcom .
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we’re just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we’ve started: Improving human health.
Position Summary Join our dynamic and growing global team as a Study Coordinator (SC), where you’ll play a pivotal role in the conduct of clinical trials. You’ll be responsible for a variety of activities essential to the success of these trials, including trial start‑up activities, ongoing study management, and coordination of trial subjects at every stage of their clinical trial journey. As the main point of contact for trial subjects, you’ll work closely with the Principal Investigator (PI) to ensure the safety of patients and the integrity of data collected, in accordance with study protocol requirements, Good Clinical Practice (GCP), and applicable regulatory requirements.
Essential Duties and Responsibilities
Ensure the smooth and efficient day‑to‑day operation of clinical trials.
Schedule and manage subject visits, including unscheduled visits, as per protocol requirements.
Recruit, consent, screen, instruct, and coordinate research subjects.
Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Dexcom’s SOPs.
Identify and elevate safety events and major protocol deviations.
Assist with assessing trends for safety and protocol deviations and communicate findings to the PI. Propose and implement corrective and preventative actions.
Trial Planning and Coordination
Provide documents and information for Ethics Committee applications.
Perform tasks as delegated by the PI in accordance with the protocol, SOPs, and applicable guidelines.
Assist in finding potential subjects through pre‑screening activities.
Prepare supplies and account for devices required for clinical studies.
Set up IT equipment for studies.
Develop clinical study materials (including, but not limited to, source documentation, IRB submissions, training slides, etc.).
Data Collection and Management
Ensure timely and accurate completion of Case Report Forms (CRF/e‑CRF) and resolve queries.
Maintain essential study documents/files and make records available for review, including but not limited to device accountability tracking.
Keep an ongoing record and assessment of adverse events (AEs) and serious adverse events (SAEs).
Assist with departmental audits of clinical studies and procedures.
Compliance and Ethics
Ensure trial practices reflect ethical and legal standards for clinical trials.
Adhere to all Dexcom SOPs, ISO 14155:2020, and Malaysian Guideline for Good Clinical Practice.
Notify the Ethics Committee of SAEs and protocol deviations.
Prepare the site for monitoring, audit, and inspection, and implement recommended corrective actions.
Administrative Support
Observe the progress of trial activities and communicate schedules/required procedures to the team.
Assist with dispensing participants’ compensation (if applicable).
Coordinate trial close‑out activities, including device investigation or disposal and archiving materials.
Involve in and contribute to all quality improvement activities of the department.
Collaborate with global Clinical PMO and study teams to establish and maintain study timelines.
Communicate effectively and professionally with coworkers, leadership, and study subjects.
Collaborate effectively with peers and leadership across departments and professionally interact/build relationships with FDA, IRB, and key opinion leaders.
Perform other duties as assigned under minimal supervision.
Required Qualifications
Degree in nursing, sciences, or pharmacy; MBBS/MD with clinical experience will also be considered.
2‑5 years relevant working experience in clinical research.
Possess GCP Certification.
Proficient with MS Office Suite.
Excellent communication skills and ability to work effectively with multiple global functions.
Strong organizational skills and ability to manage competing priorities.
Strong critical thinking and independence.
Willing to work hands‑on in an extremely fast‑paced environment with high attention to detail and accuracy.
Preferred Qualifications
Experience in continuous glucose monitoring (CGM) or diabetes‑related studies.
Experience working closely with a global team.
Experience with Clinical Trial Management Systems (e.g., Veeva).
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees, or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
Seniority Level Not Applicable
Employment Type Full‑time
Job Function Research, Analyst, and Information Technology
Industry Medical Equipment Manufacturing
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3
(Senior) Clinical Research Associate
IQVIA
Posted 15 days ago
Job Viewed
Job Description
As you develop your career as a Senior CRA or CRA, this role offers you the opportunity to plan and progress your career in the direction you choose. At IQVIA, we do not believe in a 'career ceiling.' You will be exposed to wider opportunities like operations management, dedicated customer solutions, project management and more. And you won't do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion opportunities and awards. Joining IQVIA will give you access to cutting-edge in-house technology and provide opportunities to work on global projects/ trials. You will be building a flexible, meaningful and fulfilling career with no limits.
**Your responsibilities will include:**
+ Performing site selection, initiation, monitoring, and close-out visits, plus maintaining appropriate documentation
+ Supporting the development of a subject recruitment plan
+ Establishing regular lines of communication plus administering protocol and related study training to assigned sites
+ Evaluating the quality and integrity of site practices - escalating quality issues as appropriate
+ Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
+ You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. You will need to have a good knowledge of applicable clinical research regulatory requirements.
**Qualifications:**
+ University degree in scientific discipline or healthcare
+ At least 1 year of on-site monitoring experience
+ Good knowledge of GCP and clinical research regulatory requirements
+ Good computer skills including MS Office
+ Excellent command of English language
+ Organizational, time management and problem-solving skills
+ Ability to establish and maintain effective working relationships with colleagues, managers, and customers.
+ Flexibility to travel.
**What you can expect:**
+ Working with different customers on global trials
+ Career development opportunities for those who are passionate in wanting to grow as part of the organization.
+ Leaders that support flexible work schedules/arrangement
+ Excellent working environment in a stable, international, reputable company
+ Programs to help you build your technical skills, therapeutic knowledge and regular refreshers for updates in the regulatory landscape
+ Attractive remuneration package.
#LI-Hybrid
#CRAFSAJD
#CRASDAJD
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
**Your responsibilities will include:**
+ Performing site selection, initiation, monitoring, and close-out visits, plus maintaining appropriate documentation
+ Supporting the development of a subject recruitment plan
+ Establishing regular lines of communication plus administering protocol and related study training to assigned sites
+ Evaluating the quality and integrity of site practices - escalating quality issues as appropriate
+ Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
+ You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. You will need to have a good knowledge of applicable clinical research regulatory requirements.
**Qualifications:**
+ University degree in scientific discipline or healthcare
+ At least 1 year of on-site monitoring experience
+ Good knowledge of GCP and clinical research regulatory requirements
+ Good computer skills including MS Office
+ Excellent command of English language
+ Organizational, time management and problem-solving skills
+ Ability to establish and maintain effective working relationships with colleagues, managers, and customers.
+ Flexibility to travel.
**What you can expect:**
+ Working with different customers on global trials
+ Career development opportunities for those who are passionate in wanting to grow as part of the organization.
+ Leaders that support flexible work schedules/arrangement
+ Excellent working environment in a stable, international, reputable company
+ Programs to help you build your technical skills, therapeutic knowledge and regular refreshers for updates in the regulatory landscape
+ Attractive remuneration package.
#LI-Hybrid
#CRAFSAJD
#CRASDAJD
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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This advertiser has chosen not to accept applicants from your region.
4
Senior Clinical Research Associate
Kuala Lumpur, Kuala Lumpur
PSI CRO
Posted 16 days ago
Job Viewed
Job Description
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. PSI’s business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market. By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients. We offer an inspiring story of the company that has grown organically from a handful of countries to global presence. PSI is a mature company with standards and practices, but we do not stand still. Every day, there is a figurative Everest to climb, and you will not get bored here. Job Description We’re searching for a knowledgeable, team-oriented Senior CRA to manage the clinical aspects of full-service globalprojects in Malaysia. As a Senior CRA at PSI, you will work on the frontline of communication with project stakeholders, ensuring the successful conduct of clinical trials in a variety of therapeutic indications. You willmaintain the highest quality standards in the industry, whileperforming and supervisingstudy start-up, clinical monitoring and site management activities on the country/regionallevel. You will become one of our first team members in Malaysia and contribute to the development of PSI Operations. The candidate can be based anywhere in Malaysia. You will: Supervise study activities, timelines, milestones, and schedules on the country level. Conduct and report all types of onsite monitoring visits. Be involved in study set-up, including site contract and budget negotiations. Be responsible for site communication and management. Ensure consistency of all study processes and identify country differences. Oversee maintenance of study-specific and corporate tracking systems. Contribute to the development and update of project planning documents, essential documents, and project instructions. Be a point of contact for in-house support services, contractors, global cross-functional teams, and vendors. Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations. Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols. Qualifications The ideal candidate must possess the following qualifications: Bachelor's degree in Life Sciences, Pharmacy, or Registered Nursing; or an equivalent combination of education, training, and experience. Registered pharmacists are strongly preferred. Minimum of 4-5 years of demonstrable, independent on-site monitoring experience or equivalent expertise. Extensive experience in conducting all types of monitoring visits in Phase II and/or III clinical trials. Proficiency in feasibility assessment and study set-up processes is highly desirable. Specialized experience in Oncology or Hematology therapeutic indications is a significant advantage. Demonstrated ability to plan effectively, multitask efficiently, and thrive in a dynamic team environment. Superior communication, collaboration, and problem-solving skills are essential. Willingness and ability to travel extensively within Malaysia is a prerequisite for this position. Additional Information
How are we different? PSI is privately owned by the very people who founded the company more than 25 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms. Growth Opportunities PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.
#J-18808-Ljbffr
How are we different? PSI is privately owned by the very people who founded the company more than 25 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms. Growth Opportunities PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.
#J-18808-Ljbffr
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5
(Senior) Clinical Research Associate
Petaling Jaya, Selangor
IQVIA
Posted 16 days ago
Job Viewed
Job Description
As you develop your career as a Senior CRA or CRA, this role offers you the opportunity to plan and progress your career in the direction you choose. At IQVIA, we do not believe in a ‘career ceiling.’ You will be exposed to wider opportunities like operations management, dedicated customer solutions, project management and more. And you won’t do it alone – you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion opportunities and awards. Joining IQVIA will give you access to cutting-edge in-house technology and provide opportunities to work on global projects/ trials. You will be building a flexible, meaningful and fulfilling career with no limits. Your responsibilities will include: Performing site selection, initiation, monitoring, and close-out visits, plus maintaining appropriate documentation
Supporting the development of a subject recruitment plan
Establishing regular lines of communication plus administering protocol and related study training to assigned sites
Evaluating the quality and integrity of site practices – escalating quality issues as appropriate
Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
You will need to be comfortable collaborating and communicating with a variety of colleagues and customers
. You will need to have a good knowledge of applicable clinical research regulatory requirements.
Qualifications: University degree in scientific discipline or healthcare
At least 1 year of on-site monitoring experience
Good knowledge of GCP and clinical research regulatory requirements
Good computer skills including MS Office
Excellent command of English language
Organizational, time management and problem-solving skills
Ability to establish and maintain effective working relationships with colleagues, managers, and customers.
Flexibility to travel.
What you can expect: Working with different customers on global trials
Career development opportunities for those who are passionate in wanting to grow as part of the organization.
Leaders that support flexible work schedules/arrangement
Excellent working environment in a stable, international, reputable company
Programs to help you build your technical skills, therapeutic knowledge and regular refreshers for updates in the regulatory landscape
Attractive remuneration package.
#LI-Hybrid #CRAFSAJD #CRASDAJD IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Supporting the development of a subject recruitment plan
Establishing regular lines of communication plus administering protocol and related study training to assigned sites
Evaluating the quality and integrity of site practices – escalating quality issues as appropriate
Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
You will need to be comfortable collaborating and communicating with a variety of colleagues and customers
. You will need to have a good knowledge of applicable clinical research regulatory requirements.
Qualifications: University degree in scientific discipline or healthcare
At least 1 year of on-site monitoring experience
Good knowledge of GCP and clinical research regulatory requirements
Good computer skills including MS Office
Excellent command of English language
Organizational, time management and problem-solving skills
Ability to establish and maintain effective working relationships with colleagues, managers, and customers.
Flexibility to travel.
What you can expect: Working with different customers on global trials
Career development opportunities for those who are passionate in wanting to grow as part of the organization.
Leaders that support flexible work schedules/arrangement
Excellent working environment in a stable, international, reputable company
Programs to help you build your technical skills, therapeutic knowledge and regular refreshers for updates in the regulatory landscape
Attractive remuneration package.
#LI-Hybrid #CRAFSAJD #CRASDAJD IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
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6
Senior Clinical Research Associate
Kuala Lumpur, Kuala Lumpur
PSI CRO
Posted 16 days ago
Job Viewed
Job Description
PSI CRO is a dynamic, global company founded in 1995, bringing together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. We are seeking a knowledgeable, team-oriented Senior Clinical Research Associate to manage the clinical aspects of full-service global projects in Malaysia. As a Senior CRA at PSI, you will work on the frontline of communication with project stakeholders, ensuring the successful conduct of clinical trials in a variety of therapeutic indications. Job Description
You will maintain the highest quality standards in the industry, while performing and supervising study start-up, clinical monitoring and site management activities on the country/regional level. You will become one of our first team members in Malaysia and contribute to the development of PSI Operations. Supervise study activities, timelines, milestones, and schedules on the country level. Conduct and report all types of onsite monitoring visits. Be involved in study set-up, including site contract and budget negotiations. Be responsible for site communication and management. Ensure consistency of all study processes and identify country differences. Oversee maintenance of study-specific and corporate tracking systems. Contribute to the development and update of project planning documents, essential documents, and project instructions. Be a point of contact for in-house support services, contractors, global cross-functional teams, and vendors. Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations. Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols. Qualifications
Bachelor's degree in Life Sciences, Pharmacy, or Registered Nursing; or an equivalent combination of education, training, and experience. Registered pharmacists are strongly preferred. Minimum of 4-5 years of demonstrable, independent on-site monitoring experience or equivalent expertise. Extensive experience in conducting all types of monitoring visits in Phase II and/or III clinical trials. Proficiency in feasibility assessment and study set-up processes is highly desirable. Specialized experience in Oncology or Hematology therapeutic indications is a significant advantage. Demonstrated ability to plan effectively, multitask efficiently, and thrive in a dynamic team environment. Superior communication, collaboration, and problem-solving skills are essential. PSI is an equal opportunities employer and welcomes applications from all qualified candidates.
#J-18808-Ljbffr
You will maintain the highest quality standards in the industry, while performing and supervising study start-up, clinical monitoring and site management activities on the country/regional level. You will become one of our first team members in Malaysia and contribute to the development of PSI Operations. Supervise study activities, timelines, milestones, and schedules on the country level. Conduct and report all types of onsite monitoring visits. Be involved in study set-up, including site contract and budget negotiations. Be responsible for site communication and management. Ensure consistency of all study processes and identify country differences. Oversee maintenance of study-specific and corporate tracking systems. Contribute to the development and update of project planning documents, essential documents, and project instructions. Be a point of contact for in-house support services, contractors, global cross-functional teams, and vendors. Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations. Works in partnership with IRB/IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols. Qualifications
Bachelor's degree in Life Sciences, Pharmacy, or Registered Nursing; or an equivalent combination of education, training, and experience. Registered pharmacists are strongly preferred. Minimum of 4-5 years of demonstrable, independent on-site monitoring experience or equivalent expertise. Extensive experience in conducting all types of monitoring visits in Phase II and/or III clinical trials. Proficiency in feasibility assessment and study set-up processes is highly desirable. Specialized experience in Oncology or Hematology therapeutic indications is a significant advantage. Demonstrated ability to plan effectively, multitask efficiently, and thrive in a dynamic team environment. Superior communication, collaboration, and problem-solving skills are essential. PSI is an equal opportunities employer and welcomes applications from all qualified candidates.
#J-18808-Ljbffr
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7
Clinical Research Associate II
Kuala Lumpur, Kuala Lumpur
Fortrea
Posted 16 days ago
Job Viewed
Job Description
Fortrea Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia Join or sign in to find your next job
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Clinical Research Associate II
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Fortrea Fortrea Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 4 days ago Be among the first 25 applicants Join to apply for the
Clinical Research Associate II
role at
Fortrea Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records. Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits. Prepares and implements project plans related to Clinical Monitoring responsibilities. Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements. Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems. Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial. Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements. Ensures adherence to global quality control and CRA performance metrics. Ensures audit readiness at site level. Acts in the project role of a Lead CRA as assigned. General On-Site Monitoring Responsibilities: Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data. Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required. Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy. Travel, including air travel, may be required and is an essential function of the job. Prepare and submit accurate and timely trip reports. Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management. Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management. Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems. Track IP shipments and supplies, as needed. Track and follow-up on serious adverse events as assigned. Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met. Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned. Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed. Present training content for site initiation. Assist with training of new employees (e.g., co-monitoring). All other duties as needed or assigned.
Summary Of Responsibilities
Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records. Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits. Prepares and implements project plans related to Clinical Monitoring responsibilities. Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements. Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems. Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial. Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements. Ensures adherence to global quality control and CRA performance metrics. Ensures audit readiness at site level. Acts in the project role of a Lead CRA as assigned. General On-Site Monitoring Responsibilities: Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data. Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required. Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy. Travel, including air travel, may be required and is an essential function of the job. Prepare and submit accurate and timely trip reports. Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management. Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management. Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems. Track IP shipments and supplies, as needed. Track and follow-up on serious adverse events as assigned. Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met. Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned. Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed. Present training content for site initiation. Assist with training of new employees (e.g., co-monitoring). All other duties as needed or assigned.
Qualifications (Minimum Required)
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate. Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements. Thorough knowledge of monitoring procedures. Basic understanding of the clinical trial process. Fluent in local office language and in English, both written and verbal. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required)
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND A minimum of 2 years of Clinical Monitoring experience.
Preferred Qualifications Include
Thorough working knowledge of Fortrea SOPs for site monitoring. One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. Phase I monitoring experience. Life Science or Nursing qualification. Specific skills, systems, certifications, and/or licenses preferred. Personal characteristics (leadership, problem solving, interpersonal skills). Good attention to detail. Methodical approach to work. Good understanding of medical and clinical research terminology and clinical research processes. An understanding of the basics of physiology, pharmacology, and medical devices (when applicable). Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements. Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications. Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English. Focus on Customer. Innovate and Change. Pursue Scientific and Process Excellence. Work with Others. Achieve Results. Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors. Demonstrated ability to conduct clinical operations activities most effectively and efficiently. Good analytical and negotiation skills. Experience using e-clinical systems (e.g., clinical trial management system (CTMS)). For medical device positions, experience in providing customer service to device end users.
Physical Demands/Work Environment
Must be able to sit at a computer for long periods of time. Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day. Standard office and/or home working environment. Clinical Research Unit and hospital environment (administrative only). Risk of eye strain. Will involve outside of normal office hours as required by the role. Travel Requirement is 60% of the time (traveling to study sites).
Learn more about our EEO & Accommodations request here. Seniority level
Seniority level Entry level Employment type
Employment type Full-time Job function
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Fortrea Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records. Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits. Prepares and implements project plans related to Clinical Monitoring responsibilities. Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements. Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems. Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial. Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements. Ensures adherence to global quality control and CRA performance metrics. Ensures audit readiness at site level. Acts in the project role of a Lead CRA as assigned. General On-Site Monitoring Responsibilities: Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data. Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required. Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy. Travel, including air travel, may be required and is an essential function of the job. Prepare and submit accurate and timely trip reports. Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management. Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management. Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems. Track IP shipments and supplies, as needed. Track and follow-up on serious adverse events as assigned. Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met. Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned. Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed. Present training content for site initiation. Assist with training of new employees (e.g., co-monitoring). All other duties as needed or assigned.
Summary Of Responsibilities
Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records. Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits. Prepares and implements project plans related to Clinical Monitoring responsibilities. Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements. Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems. Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial. Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements. Ensures adherence to global quality control and CRA performance metrics. Ensures audit readiness at site level. Acts in the project role of a Lead CRA as assigned. General On-Site Monitoring Responsibilities: Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data. Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required. Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy. Travel, including air travel, may be required and is an essential function of the job. Prepare and submit accurate and timely trip reports. Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management. Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management. Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems. Track IP shipments and supplies, as needed. Track and follow-up on serious adverse events as assigned. Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met. Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned. Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed. Present training content for site initiation. Assist with training of new employees (e.g., co-monitoring). All other duties as needed or assigned.
Qualifications (Minimum Required)
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate. Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements. Thorough knowledge of monitoring procedures. Basic understanding of the clinical trial process. Fluent in local office language and in English, both written and verbal. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required)
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND A minimum of 2 years of Clinical Monitoring experience.
Preferred Qualifications Include
Thorough working knowledge of Fortrea SOPs for site monitoring. One (1) or more additional years of experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred. Phase I monitoring experience. Life Science or Nursing qualification. Specific skills, systems, certifications, and/or licenses preferred. Personal characteristics (leadership, problem solving, interpersonal skills). Good attention to detail. Methodical approach to work. Good understanding of medical and clinical research terminology and clinical research processes. An understanding of the basics of physiology, pharmacology, and medical devices (when applicable). Good understanding of the principles of ICH GCP, ISO 14155 (if applicable) and local regulatory requirements. Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications. Good oral and written internal and external communication. Strong interpersonal team and organizational skills, personal presentation. The ability to communicate effectively in English. Focus on Customer. Innovate and Change. Pursue Scientific and Process Excellence. Work with Others. Achieve Results. Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors. Demonstrated ability to conduct clinical operations activities most effectively and efficiently. Good analytical and negotiation skills. Experience using e-clinical systems (e.g., clinical trial management system (CTMS)). For medical device positions, experience in providing customer service to device end users.
Physical Demands/Work Environment
Must be able to sit at a computer for long periods of time. Must be able to use hands to finger, handle or touch objects, tools or controls, including a computer keyboard, for up to 8 hours per day. Standard office and/or home working environment. Clinical Research Unit and hospital environment (administrative only). Risk of eye strain. Will involve outside of normal office hours as required by the role. Travel Requirement is 60% of the time (traveling to study sites).
Learn more about our EEO & Accommodations request here. Seniority level
Seniority level Entry level Employment type
Employment type Full-time Job function
Job function Research, Analyst, and Information Technology Referrals increase your chances of interviewing at Fortrea by 2x Get notified about new Clinical Research Associate jobs in
Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia . Petaling Jaya, Selangor, Malaysia 2 hours ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 4 days ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 3 weeks ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 days ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 week ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 weeks ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 weeks ago Clinical Studies Specialist Coordinator III
Petaling Jaya, Selangor, Malaysia 2 days ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 days ago Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 3 months ago Trial Capabilities Senior Associate For Asia Pacific Region
Petaling Jaya, Selangor, Malaysia 4 days ago Research Assistant/Analyst/Associate, Global Credit - Ratings and Monitoring
Rep II - Customer Service Shared Services
Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Sr Clinical Research Associate (CRA)
Kuala Lumpur, Kuala Lumpur
BioQuest Solutions
Posted 16 days ago
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Job Description
Overview
Position Title/Designation: Sr Clinical Research Associate (CRA) Location: Malaysia Experience Required: 3–4 years of CRA experience Key Responsibilities
Manage assigned clinical studies, support sites with EC approvals, training. End to End site Management Ensure compliance with SOPs, GCP & regulatory requirements. Act as main point of contact for sites, ensuring smooth study conduct, accurate data & SAE reporting. Coordinate with internal teams, labs & vendors; track invoices & study supplies as applicable How to apply
Ready to explore new opportunities! Write to us at:
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Position Title/Designation: Sr Clinical Research Associate (CRA) Location: Malaysia Experience Required: 3–4 years of CRA experience Key Responsibilities
Manage assigned clinical studies, support sites with EC approvals, training. End to End site Management Ensure compliance with SOPs, GCP & regulatory requirements. Act as main point of contact for sites, ensuring smooth study conduct, accurate data & SAE reporting. Coordinate with internal teams, labs & vendors; track invoices & study supplies as applicable How to apply
Ready to explore new opportunities! Write to us at:
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Is this job a match or a miss?
This advertiser has chosen not to accept applicants from your region.
9