25 Icon Plc jobs in Malaysia

Tigermed Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Clinical Research Associate

Tigermed Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

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1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations.

1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget.

2.Responsibilities

(a) Site management

•Study site selection, initiation (SIV) and clinical monitoring.

•Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.

•Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.

•Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.

•Track study recruitment to ensure recruitment target is achieved in all studies.

•Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.

•Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.

•Assemble site specific EC submission dossier, and ensure submission to EC.

Training

•Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.

•Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.

Documentation

•Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.

•Prepare/complete study records’ archiving according to protocol and sponsor requirements.

(b) Drug Safety

•Ensure safety information is disseminated to all sites according SOP and applicable regulations.

•Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.

(c) Finance and Administration

•Finalize budget and obtain signed contract from site, prior to site initiation visit.

•Ensure Study Payment Schedule is executed and retain relevant documents/receipts.

(d) Study Tools and system

•Update and maintain Study tools/systems in a timely manner.

3. Qualifications

3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements;

3.2 At least 1 year of CRA experience;

3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;

3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Seniority level

• Seniority level Associate

Employment type

• Employment type Full-time

Job function

• Job function Research
• Industries Pharmaceutical Manufacturing

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Clinical Research Associate page is loadedClinical Research Associate Apply remote type Hybrid locations MYS - Selangor - Petaling Jaya (Ascent Paradigm) time type Full time posted on Posted 2 Days Ago time left to apply End Date: August 16, 2025 (4 days left to apply) job requisition id R353235

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:

08/16/2025

*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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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Mason & Co Federal Territory of Kuala Lumpur, Malaysia

Clinical Research Associate

Mason & Co Federal Territory of Kuala Lumpur, Malaysia

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Direct message the job poster from Mason & Co

Recruiter for the Life Sciences Industry | Associate Consultant at Mason & Co.

About the company

This employer is a multinational company specializing in clinical research and trial management services for the healthcare sector. Their comprehensive research solutions support medical advancement initiatives across multiple therapeutic areas and they have established themselves as a trusted and respected partner within the global healthcare research community.

About the job

In this position, you will be providing clinical oversight, site management and regulatory support services related to medical research studies. This role also involves contribution to data quality assurance activities in collaboration with clinical operations and sponsor teams.

Job Responsibilities:

• Provide site support through consultation on study protocol and regulatory matters
• Handle monitoring activities along with data verification at clinical research sites
• Work collaboratively with clinical teams on study implementation and compliance activities, offering guidance and assistance as necessary
• Develop monitoring reports and documentation as required for regulatory submissions
• Contribute to operational excellence by implementing best practices and driving quality improvements

Job Requirements:

• Bachelor's Degree in Life Sciences, Nursing, Medicine or other healthcare-related fields
• Minimum of 1 year working experience in clinical research or healthcare industry
• Ability to work independently and manage multiple study sites
• Excellent analytical, communication and problem-solving skills
• Extensive travel required to clinical research sites across assigned regions

What’s on offer:

• Exciting career progression opportunities in a leading industry player
• Competitive remuneration and benefits
• The chance to be part of a growing industry that makes a difference in people’s lives

Seniority level

• Seniority level Associate

Employment type

• Employment type Full-time

Job function

• Job function Quality Assurance, Research, and Project Management
• Industries Hospitals and Health Care, Public Health, and Health and Human Services

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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: R353235

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Tigermed Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia Clinical Research Associate

Tigermed Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Tigermed 1.1 This position is responsible for project management and study site management from site selection to initiation until monitoring and close-out of assigned clinical study studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP) and other applicable regulations. 1.2 The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time and within budget. 2.Responsibilities (a) Site management •Study site selection, initiation (SIV) and clinical monitoring. •Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience. •Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations. •Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP. •Track study recruitment to ensure recruitment target is achieved in all studies. •Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating. •Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study. •Assemble site specific EC submission dossier, and ensure submission to EC. Training •Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements. •Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. Documentation •Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files. •Prepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety •Ensure safety information is disseminated to all sites according SOP and applicable regulations. •Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Administration •Finalize budget and obtain signed contract from site, prior to site initiation visit. •Ensure Study Payment Schedule is executed and retain relevant documents/receipts. (d) Study Tools and system •Update and maintain Study tools/systems in a timely manner. 3. Qualifications 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. The excellent candidates will not be restricted to the current requirements; 3.2 At least 1 year of CRA experience; 3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; 3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc. Seniority level

Seniority level Associate Employment type

Employment type Full-time Job function

Job function Research Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Tigermed by 2x Get notified about new Clinical Research Associate jobs in

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia . We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr

Clinical Research Associate page is loaded Clinical Research Associate Apply remote type Hybrid locations MYS - Selangor - Petaling Jaya (Ascent Paradigm) time type Full time posted on Posted 2 Days Ago time left to apply End Date: August 16, 2025 (4 days left to apply) job requisition id R353235 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: 08/16/2025

*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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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Mason & Co Federal Territory of Kuala Lumpur, Malaysia Clinical Research Associate

Mason & Co Federal Territory of Kuala Lumpur, Malaysia Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Mason & Co Recruiter for the Life Sciences Industry | Associate Consultant at Mason & Co.

About the company This employer is a multinational company specializing in clinical research and trial management services for the healthcare sector. Their comprehensive research solutions support medical advancement initiatives across multiple therapeutic areas and they have established themselves as a trusted and respected partner within the global healthcare research community. About the job In this position, you will be providing clinical oversight, site management and regulatory support services related to medical research studies. This role also involves contribution to data quality assurance activities in collaboration with clinical operations and sponsor teams. Job Responsibilities: Provide site support through consultation on study protocol and regulatory matters Handle monitoring activities along with data verification at clinical research sites Work collaboratively with clinical teams on study implementation and compliance activities, offering guidance and assistance as necessary Develop monitoring reports and documentation as required for regulatory submissions Contribute to operational excellence by implementing best practices and driving quality improvements Job Requirements: Bachelor's Degree in Life Sciences, Nursing, Medicine or other healthcare-related fields Minimum of 1 year working experience in clinical research or healthcare industry Ability to work independently and manage multiple study sites Excellent analytical, communication and problem-solving skills Extensive travel required to clinical research sites across assigned regions What’s on offer: Exciting career progression opportunities in a leading industry player Competitive remuneration and benefits The chance to be part of a growing industry that makes a difference in people’s lives Seniority level

Seniority level Associate Employment type

Employment type Full-time Job function

Job function Quality Assurance, Research, and Project Management Industries Hospitals and Health Care, Public Health, and Health and Human Services Referrals increase your chances of interviewing at Mason & Co by 2x Sign in to set job alerts for “Clinical Research Associate” roles.

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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

#J-18808-Ljbffr

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

#J-18808-Ljbffr