Clinical Trial Coordinator

MSD Malaysia; Gurugram District; On-site; INR 400,000 - 700,000; Full time

Benefits offered by this job

VISA Sponsorship

Job summary

MSD Malaysia seeks a Clinical Trial Coordinator to oversee trial and site administration, maintain documents, and assist with regulatory submissions. You will coordinate budgets, CTMS/eTMF updates, and supplier management across country roles, ensuring Site Ready timelines.

The role requires adaptability, strong documentation skills, and experience in clinical trials. VISA sponsorship and regular employment status are noted, with travel as needed.

Qualifications

• Experience in clinical research and site management is essential.
• Knowledge of regulatory submissions, CTRAs and budgets is beneficial.
• Ability to track essential documents and maintain study tools.

Responsibilities

• Track and report essential documents and safety reports.
• Update CTMS and trackers for trials and sites.
• Manage clinical and non-clinical supply coordination.
• Prepare translation/change requests with other country roles.
• Develop and maintain study budgets and contracts.
• Organize meetings and support investigator sessions.
• Ensure timely submission packages for IRB/ERC and authorities.

Skills

Clinical Research

Site Management

Documentation

Budgeting & Payments

Regulatory Affairs

Cross-Cultural Awareness

Data Archiving

IRB/ERC Submissions

CTMS Updates

eTMF Reconciliation

Tools

CTMS

eTMF

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.