Clinical Trial Coordinator

MSD Malaysia; Gurgaon; On-site; INR 420,000 - 660,000; Full time

Job summary

MSD Malaysia is seeking a Clinical Trial Coordinator to oversee trial and site administration, manage documents, track budgets, and support regulatory submissions. You will collaborate with cross-functional teams to ensure site readiness and timely delivery of study materials.

The role requires strong knowledge of clinical research processes, CTMS usage, and regulatory compliance, with flexibility for local travel and visa sponsorship where applicable.

Qualifications

• Experience in clinical trial coordination and site administration.
• Knowledge of CTMS, trial documentation, and regulatory submissions.
• Familiarity with ICH GCP guidelines and CTRAs is a plus.

Responsibilities

• Track essential documents and report safety events.
• Coordinate distribution and archiving of trial tools and documents.
• Update CTMS and trackers; manage trial budgets and contracts.
• Support regulatory submissions to IRB/ERC and Health Authorities.
• Organize investigator meetings and prepare study materials.

Skills

Clinical Research

Clinical Trial Management

Regulatory Compliance

Data Archiving

Documentation

Job description

Job Description Clinical Trial Coordinator Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable. The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.

Responsibilities

Trial and Site Administration

• Track (e.g. essential documents) and report (e.g. Safety Reports)
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
• Clinical supply & non-clinical supply management, in collaboration with other country roles
• Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)

Document Management

• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF
• Assist with eTMF reconciliation
• Execute eTMF Quality Control Plan
• Update manuals/documents (e.g., patient diaries, instructions)
• Document proper destruction of clinical supplies.
• Prepare Investigator trial file binders
• Obtain translations of documents

Regulatory & Site Start-Up Responsibilities

• In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
• Obtain, track and update study insurance certificates
• Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
• Publish study results for GCTO and RA where required per local legislation

Budgeting, Agreement and Payments

• Develop, control, update and close-out country and site budgets (including Split site budget)
• Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
• Track and report contract negotiations
• Update and maintain contract templates (in cooperation with Legal Department)
• Calculate and execute payments (to investigators, vendors, grants)
• Ensure adherence to financial and compliance procedures
• Monitor and track adherence and disclosures
• Maintain tracking tools
• Obtain and process FCPA documentation in a timely manner

Meeting Planning

• Organize meetings (create & track study memos/letters/protocols)
• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

Required Skills

• Adaptability
• Best Practices Research
• Clinical Research
• Clinical Site Management
• Clinical Trial Agreements (CTA)
• Clinical Trial Compliance
• Clinical Trial Documentation
• Clinical Trial Management
• Clinical Trial Planning
• Clinical Trials
• Clinical Trials Monitoring
• Clinical Trials Operations
• Cross-Cultural Awareness
• Data Archiving
• Economic Forecasting
• Financial Administration
• Financial Forecasting
• ICH GCP Guidelines
• Legal Archiving
• Medical Research
• Patient Recruitment
• Pharmacovigilance
• Regulatory Affairs Compliance
• Regulatory Compliance

Employee Status: Regular

Relocation: VISA Sponsorship

Travel Requirements: Flexible Work Arrangements: Not Applicable

Shift: Valid Driving License

Hazardous Material(s):

Job Posting End Date: 08/26/2026 *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.

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.