195 Clinical Research jobs in Malaysia

Overview

Join to apply for the Clinical Research Associate role at MSD .

Location: Based in Malaysia.

MSD is a premier biopharmaceutical company with a long history, focused on turning breakthrough science into medicines and vaccines that save and improve lives around the world. We are committed to discovering new solutions for today and the future, and to maintaining a diverse, inclusive workplace.

• 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, ensure 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.
• Act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
• Actively develop and expand the territory for clinical research, finding and developing new sites. Participate in internal meetings and workstreams as SME for monitoring processes and systems.

• Develop strong site relationships and ensure continuity of site relationships through all phases of the trial.
• Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and related documents.
• Gain an in-depth understanding of the study protocol and related procedures.
• Coordinate and manage various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participate and provide inputs on site selection and validation activities.
• Perform remote and on-site monitoring and oversight activities using various tools to ensure data are complete, accurate and unbiased.
• Protect subjects’ right, safety and well-being.
• Conduct site visits (validation, initiation, monitoring, close-out) and prepare clear, comprehensive visit and contact reports in a timely manner.
• Collect, review, and monitor required regulatory documentation for study start-up, maintenance and close-out.
• Communicate with Investigators and site staff on protocol conduct, recruitment, retention, deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identify, assess and resolve site performance, quality or compliance problems and escalate as needed.
• Collaborate with internal teams (GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations) and external vendors and regulatory authorities in support of assigned sites.
• Manage and maintain information in CTMS, eTMF and other systems per timelines.
• Contribute to CRA team knowledge by sharing best practices, recommending improvements and providing training as needed.
• Support and/or lead audit/inspection activities as needed.
• Contribute to identifying new potential sites and help develop their clinical research capabilities.
• Mentor/junior CRAs on process and study requirements and perform co-monitoring visits where appropriate.

• Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travel ~2-3 days/week.
• Current driver’s license preferred (must have in certain countries).

CORE Competency Expectations

• Fluent in local languages and English (verbal and written) with excellent communication skills.
• Strong knowledge of clinical research, trial phases, GCP/ICH and country clinical research laws and guidelines.
• Understanding of Global/Regional guidelines and ability to work within these guidelines.
• Hands-on knowledge of Good Documentation Practices.
• Proven skills in site management and monitoring with independent judgment.
• Good IT skills and ability to adapt to new IT applications.
• Ability to analyze data/metrics and act accordingly.
• Capable of managing complex issues in a solution-oriented manner.
• Performs root cause analysis and implements corrective actions.

Behavioural Competency Expectations

• Effective time management, organizational and interpersonal skills; problem solving and conflict management.
• Ability to work independently across multiple protocols and sites.
• High accountability and urgency with ability to prioritize in a changing environment.
• Works well in a matrix, multicultural environment with culturally sensitive relationships.
• Strong customer focus and commitment to quality and compliance.
• Positive growth mindset and self-driven attitude.
• Professional demeanor and communication aligned with organizational policies.

Experience Requirements

• Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

Educational Requirements

• B.A./B.S. with strong emphasis in science and/or biology.

We are dedicated to saving and improving lives and welcome diverse, talented, and committed people who bring forward varied ideas in an inclusive environment. We are an equal opportunity employer.

Current Employees apply HERE. Current Contingent Workers apply HERE. Merck & Co., Inc. does not accept unsolicited assistance from search firms for employment opportunities. This posting is active until the listed end date. Requisition ID R .

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.

• 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, and subjects’ right, safety, and well-being are protected.
• Conducts site visits, including 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.

• Ability to travel domestically and internationally approximately 65%-75% of working time.

Expected traveling ~2-3 days/week. Current driver’s license preferred (Must have in certain countries).

• 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 analyze 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.

Min. 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

B.A./B.S. with strong emphasis in science and/or biology (Preferred).

We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Preferred Skills:

Job Posting End Date:

*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

Job Description & Requirements

1. Responsible for performing all monitoring aspects of clinical trials and assist to set up, review and maintain project files to ensure compliance as stated in ICH E6 GCP to assure all trials are conducted in strict adherence to good clinical practices, regulatory obligations, investigator integrity and compliance with project specific requirements

2. Responsible for preparing, organizing, managing feasibility, site selection and investigator identification, initiation, monitoring an close-out visits in accordance with sponsor's and/or company's standard operating procedures (SOPs) and study requirements with the highest standards

3. Planning, develop, compile and/or review all study-related regulatory and administrative documents from investigational sites, monitoring visit reports, work progression reports and other study-required documents

4. Develop, compile and/or submit dossiers include initial/amendment/interim report/safety reporting to regulatory and/or ethics committee for review and follow up until approval, as required

5. Management in planning, coordinating, organizing and attending all study-related meetings and activities for sites as required

6. Manage/support project(s) in the capacity of lead CRA role and/or other designated project roles to undertake all or partial responsibilities and tasks as required, whenever designated by the Company

7. Support/Assist in Site and CRO audit or inspection as required

8. Support business development activities (e.g. search new project related information) as required

9. Support/assist in regulatory research/consultancy tasks in relation to clinical trial planning, conduction and product application/registration

10 Proactively identify and facilitate resolution of complex study problems and issues.

1. Actively work towards achieving good personal relationships with the project Team members

Work Experiences, Skills and Personal Qualities

• Minimum 3 years relevant experience in clinical research in healthcare, pharmaceutical and/or CRO industry or is a qualified pharmacist or medical doctor by training with no previous experience in relevant experience in clinical research
• Preferably has experienced in clinical study monitoring
• Good knowledge of medical terminology and clinical/medical practices

This will be a 6 months or 1 year contract position and more information will be shared during interview process.

Job Type: Full-time

Pay: RM4, RM7,000.00 per month

Benefits:

• Cell phone reimbursement
• Health insurance
• Professional development
• Work from home

Ability to commute/relocate:

• Kuala Lumpur: Reliably commute or planning to relocate before starting work (Required)

Work Location: In person

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.

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 PM 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

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.

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
10/11/2025

• A job posting is effective until PM 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