Clinical Trial Coordinator

MSD; Gurugram District; On-site; INR 350,000 - 550,000; Full time

Job summary

MSD is seeking a Clinical Trial Coordinator to manage trial and site administration, ensure timely document handling, and support regulatory submissions. The role collaborates with COM, CRM, CRA, and finance to maintain CTRAs, budgets, and payments.

The candidate should possess strong clinical research knowledge, ICH GCP compliance, and excellent documentation skills to ensure site readiness and study integrity across the country.

Qualifications

• Experience in clinical trial management and site coordination.
• Proficiency with ICH GCP guidelines and regulatory submissions.
• Ability to manage CTRAs and site start-up activities.
• Strong documentation and archiving skills for eTMF and documents.
• Cross-cultural collaboration with country roles and stakeholders.

Responsibilities

• Oversee trial and site administration and ensure timely document handling.
• Track essential documents, safety reports, and study tools; report findings.
• Coordinate labeling changes and translations with country teams as needed.
• Update CTMS and trackers; assist with eTMF reconciliation and quality control.
• Support preparation of submission packages for IRB/ERC and regulatory authorities.
• Assist budgeting, contracting, and payments for investigators and vendors.

Skills

Adaptability

Clinical Research

Clinical Site Management

CTA/CTAs

Regulatory Compliance

ICH GCP Guidelines

Budgeting/Payments

Documentation/Archiving

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 Include, But Are Not Limited To

• 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 Collaborate with other country roles to
• 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

Collaborate with finance/budgeting representatives for

• 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

Flexible Work Arrangements

Not Applicable

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.

Requisition ID

R411062