MSD is hiring for the position of Clinical Trial Coordinator in Gurgaon, Haryana. The role focuses on comprehensive trial and site administration, clinical document management, regulatory and site start-up support, clinical supplies, trial tracking, contracts, payments, and meeting coordination.

The Clinical Trial Coordinator will work under the oversight of the line manager and collaborate locally with COM, CRM, CRA, finance, and budgeting representatives to support clinical trial activities.

Job Overview

Application deadline note: The job posting states that candidates should apply no later than the day before the listed job posting end date.

About the Role

The Clinical Trial Coordinator is responsible for comprehensive trial and site administration, including preparing, collating, distributing, and archiving clinical documents.

The CTC supports clinical and non-clinical supply management and ensures the timely maintenance of tracking and reporting tools. The position also supports planned Site Ready dates by assisting with submission packages for IRB/ERC and Health Authorities.

The role collaborates closely with COM, CRM, and CRA at the local level and works with finance and budgeting representatives on Clinical Trial Research Agreements (CTRAs) and payments.

Roles & Responsibilities

Trial and Site Administration

• Track essential documents and report safety reports.
• Ensure collation and distribution of study tools and documents.
• Update Clinical Trial Management System (CTMS) databases and trackers.
• Support clinical and non-clinical supply management in collaboration with other country roles.
• Manage labeling requirements.
• Coordinate and sign translation change requests where applicable.

Clinical Document Management

• Prepare clinical trial documents and correspondence.
• Collate, distribute, ship, and archive clinical documents, including eTMF documentation.
• Assist with eTMF reconciliation.
• Execute the eTMF Quality Control Plan.
• Update manuals and documents, including patient diaries and instructions.
• Document the proper destruction of clinical supplies.
• Prepare Investigator Trial File binders.
• Obtain document translations.

Regulatory & Site Start-Up

• Provide and collect investigator forms and lists for site evaluation, validation, site start-up, and submissions.
• Obtain, track, and update study insurance certificates.
• Support preparation of submission packages for IRB/ERC.
• Support regulatory agency submissions.
• Publish study results for GCTO and RA where required under local legislation.

Budgeting, Agreements & Payments

In collaboration with finance and budgeting representatives:

• Develop, control, update, and close out country and site budgets, including split-site budgets.
• Develop, negotiate, approve, and maintain contracts such as CTRAs.
• Track and report contract negotiations.
• Update and maintain contract templates in cooperation with the Legal Department.
• Calculate and execute payments to investigators, vendors, and 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 and create and track study memos, letters, and protocols.
• Support local investigator meetings.
• Coordinate invitations and prepare meeting materials.
• Support venue selection and vendors where applicable.

Qualifications

The job description does not specify any educational qualification or degree requirement.

Required Skills

The job description lists the following 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

How to Apply

Application Link