Senior Clinical Research Associate

Merck Gruppe - MSD Sharp & Dohme; Petaling Jaya; On-site; MYR 70,000 - 110,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme in Malaysia seeks a Clinical Research Associate to oversee performance and compliance of assigned clinical trial protocols and sites, reporting to the CRA Manager or CRD. You will ensure conduct aligns with ICH-GCP, local regulations, and company procedures while maintaining site contact and overall site management.

In this role you will support start-up activities, feasibility, site validation, and remote/on-site monitoring, ensuring data integrity, participant

Qualifications

• Strong knowledge of ICH-GCP, local regulations, and trial processes.
• Ability to independently manage multiple sites and priorities.
• Excellent communication and stakeholder management skills.
• Experience with regulatory documentation and CTMS/eTMF systems.
• Experience with site visits and monitoring activities.

Responsibilities

• Develop and maintain relationships with investigators and study sites throughout all phases of the clinical trial.
• Perform site management and monitoring in compliance with ICH-GCP guidelines, Sponsor SOPs, local laws and study protocol.
• Coordinate and manage study start-up activities to achieve Site Ready status.
• Participate in site identification, selection, feasibility, and validation activities.
• Conduct remote and on-site monitoring to ensure data integrity and participant safety.
• Conduct site visits (SIVs, routine monitoring, close-out) and prepare visit reports.
• Maintain regulatory documentation for study start-up, maintenance, and close-out; ensure CTMS/eTMF systems are up to date.

Skills

Site Management

Clinical Monitoring

ICH-GCP

Regulatory Compliance

Cross-functional Collaboration

Mentorship

Job description

Job Description

This role is accountable for the performance and compliance of assigned clinical trial protocols and sites within the country.

Under the oversight of the CRA Manager or Clinical Research Director (CRD), the incumbent ensures that study conduct complies with ICH/GCP guidelines, country regulations, company policies and procedures, quality standards, and adverse event reporting requirements.

The role serves as the primary site contact and site manager throughout all phases of a clinical research study, assuming overall responsibility for assigned sites. The incumbent will also contribute to expanding the local clinical research footprint by identifying and developing new research sites and participating as a Subject Matter Expert (SME) in monitoring processes and systems.

Key Responsibilities

Site Management & Monitoring

• Develop and maintain strong relationships with investigators and study sites throughout all phases of the clinical trial.

• Perform site management and monitoring activities in compliance with:

  • ICH-GCP guidelines

  • Sponsor SOPs

  • Local laws and regulations

  • Study protocol

  • Site Monitoring Plan

  • Associated study documents

• Gain a thorough understanding of study protocols and related procedures.

• Coordinate and manage study start-up activities in collaboration with cross-functional stakeholders to achieve Site Ready status.

• Participate in site identification, selection, feasibility, and validation activities.

• Conduct remote and on-site monitoring activities to ensure:

  • Data generated by sites are complete, accurate, and unbiased.

  • Participant rights, safety, and well-being are protected.

• Conduct site visits, including:

  • Site validation visits

  • Site initiation visits (SIVs)

  • Routine monitoring visits

  • Close-out visits

• Prepare clear, comprehensive, and timely visit reports and non-visit contact documentation.

Regulatory & Documentation Management

• Collect, review, and oversee required regulatory documentation for:

Study start-up

• Study maintenance

• Study close-out

• Ensure regulatory documents are complete, accurate, and maintained in accordance with applicable requirements.

• Maintain study information and documentation in:

  • Clinical Trial Management System (CTMS)

  • Electronic Trial Master File (eTMF)

  • Other relevant clinical systems

Site Performance, Quality & Compliance

• Communicate with investigators and site personnel regarding:

  • Protocol conduct

  • Patient recruitment and retention

  • Protocol deviations

  • Regulatory requirements

  • Site audits and inspections

  • Overall site performance

• Identify, assess, and resolve site performance, quality, and compliance issues.

• Escalate significant issues through the established escalation pathway when appropriate.

• Support and/or lead audit and inspection activities.

• Perform quality control visits when delegated and appropriately trained.

Cross-Functional Collaboration

• Partner with internal stakeholders, including:

  • Country Clinical Operations

  • Finance

  • Regulatory Affairs

  • Pharmacovigilance

  • Legal

  • Regional Operations

  • Global Functional Teams

• Collaborate with external stakeholders such as:

  • Investigators

  • Site staff

  • Vendors

  • Ethics Committees (IRBs/IECs)

  • Regulatory Authorities

Clinical Research Site Development

• Support country clinical research strategies by identifying and developing new potential research sites.

• Work closely with investigators and site staff to enhance site capabilities and foster long-term partnerships.

• Contribute to the growth of the local clinical research network and trial delivery capacity.

Knowledge Sharing & Mentorship

• Act as a Subject Matter Expert (SME) for clinical monitoring processes and systems.

• Share best practices and recommend continuous process improvements.

• Provide training and guidance to team members as required.

• Mentor and support junior Clinical Research Associates through:

  • Buddy programs

  • Coaching

  • Co-monitoring visits

Key Success Factors

• Strong knowledge of ICH-GCP, local regulations, and clinical trial processes.

• Ability to independently manage multiple sites and priorities.

• Strong communication and stakeholder management skills.

• Excellent problem-solving and risk assessment capabilities.

• Commitment to quality, compliance, and patient safety.

• Ability to work effectively in a cross-functional and global environment.

Required Skills:

• Accountability
• Adaptability
• Adverse Event Report
• Biopharmaceutical Industry
• Clinical Data Management
• Clinical Development
• Clinical Research
• Clinical Research Organizations (CRO) Management
• Clinical Site Management
• Clinical Site Monitoring
• Clinical Study Management
• Clinical Trial Compliance
• Clinical Trial Documentation
• Clinical Trial Management
• Clinical Trial Planning
• Clinical Trials Monitoring
• Customer-Focused
• Good Clinical Data Management Practice (GCDMP)
• Medical Research
• Patient Recruitment
• Pharmacokinetics
• Pharmacotherapeutics
• Pharmacovigilance
• Regulatory Documents
• Task Management

Preferred Skills:

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/6/2026

*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:R410213