Senior Clinical Research Associate

MSD; Petaling Jaya; Hybrid; MYR 120,000 - 180,000; Full time

Job summary

MSD in Malaysia seeks a Senior Clinical Research Site Manager to oversee performance and compliance of clinical trial protocols across sites within the country. Under CRA Manager/CRD oversight, ensure study conduct adheres to ICH-GCP, local laws, and sponsor requirements.

The role serves as primary site contact, manages site performance, and identifies new sites to grow the local clinical research footprint.

Qualifications

• Strong knowledge of ICH-GCP, local regulations, and clinical trial processes.
• Experience managing multiple sites and coordinating cross-functional teams.
• Ability to train and mentor junior staff and conduct site monitoring visits.

Responsibilities

• Develop and maintain strong relationships with investigators and study sites across all trial phases.
• Perform site management and monitoring in accordance with ICH-GCP, sponsor SOPs, local regulations, and study protocols.
• Coordinate site start-up activities and assist in site identification, feasibility, and validation.
• Conduct remote/on-site monitoring to ensure data integrity and participant safety.
• Prepare visit reports and regulatory documentation; manage CTMS/eTMF records.
• Support regulatory documentation, site performance, and quality/compliance activities.
• Collaborate with cross-functional teams and external stakeholders to expand clinical research footprint.

Skills

Accountability

Adaptability

Adverse Event Report

Biopharmaceutical Industry

Clinical Data Management

Clinical Development

Clinical Research

CRO Management

Clinical Site Management

Clinical Site Monitoring

Clinical Study Management

Clinical Trial Compliance

Clinical Trial Documentation

Clinical Trial Management

Clinical Trial Planning

Clinical Trial Monitoring

Customer-Focused

GCDMP

Medical Research

Patient Recruitment

Pharmacokinetics

Pharmacotherapeutics

Pharmacovigilance

Regulatory Documents

Task Management

Job description

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

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 Trial Monitoring, Customer-Focused, Good Clinical Data Management Practice (GCDMP), Medical Research, Patient Recruitment, Pharmacokinetics, Pharmacotherapeutics, Pharmacovigilance, Regulatory Documents, Task Management

Preferred Skills

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)

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