MSD Hiring For Senior Associate, Clinical Research

MSD (Merck Sharp & Dohme) is inviting applications for the position of Senior Associate, Clinical Research at its Gurgaon, Haryana, location. The role covers clinical trial and site administration, clinical documentation, regulatory submissions, site start-up activities, budget management, contracts, investigator payments, and clinical research meeting coordination.

The application deadline is October 25, 2026. Candidates should review the posting deadline instructions carefully before applying.

Job Details

Position

Senior Associate, Clinical Research

The role supports clinical trial operations and site administration, documentation management, regulatory compliance, financial processes, and coordination with investigators and internal teams.

Key Responsibilities

1. Clinical Trial and Site Administration

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

2. Clinical Document Management

• Prepare clinical documents and correspondence.
• Distribute, ship, and archive clinical documents, including electronic Trial Master File (eTMF) records.
• Assist with eTMF reconciliation and execute the eTMF Quality Control Plan.
• Update study manuals and documents, including patient diaries and instructions.
• Prepare investigator trial file binders and obtain document translations.
• Document the proper destruction of clinical supplies.

3. Regulatory Affairs and Site Start-Up

• Coordinate site evaluation, validation, start-up, and submission documentation with country teams.
• Obtain, track, and update study insurance certificates.
• Support Institutional Review Board (IRB) and Ethics Review Committee (ERC) submission packages and regulatory agency submissions.
• Publish study results for GCTO and Regulatory Affairs (RA), where required by local legislation.

4. Budgeting, Contracts, and Payments

• Develop, monitor, update, and close out country and site budgets.
• Develop, negotiate, approve, and maintain Clinical Trial Research Agreements (CTRAs) and other contracts.
• Track contract negotiations and maintain contract templates with the Legal Department.
• Calculate and process payments to investigators, vendors, and grants.
• Follow financial and compliance procedures.
• Monitor compliance, disclosures, and tracking tools.
• Obtain and process Foreign Corrupt Practices Act (FCPA) documentation within required timelines.

5. Meeting Coordination

• Organize meetings and prepare or track study memos, letters, and protocols.
• Support local investigator meetings.

Eligibility and Qualifications

The supplied job description emphasizes clinical research knowledge, relevant guidelines, documentation practices, and clinical IT skills.

Candidates should have:

• Knowledge of Good Clinical Practice (GCP) and ICH-GCP guidelines appropriate to the role.
• An understanding of global, country, and regional clinical research guidelines.
• Hands-on knowledge of Good Documentation Practices.
• Strong Microsoft Excel skills and proficiency with Microsoft Office.
• The ability to use clinical IT applications and adapt to new systems.
• Fluency in local languages and business-proficient English, both written and verbal.

Required Skills

Key skills highlighted in the MSD Senior Associate, Clinical Research job posting include:

• Clinical Research and Clinical Trial Management
• Clinical Trial Operations and Support
• Clinical Trial Documentation and Compliance
• Clinical Data Management
• Clinical IT Applications
• Good Clinical Practice (GCP) and ICH-GCP
• Document Management and Documentation Preparation
• Budget Development and Data Analysis
• Contract Processing and Negotiation
• Drug Regulatory Affairs
• Analytical Problem-Solving and Decision-Making
• Time Management and Organizational Skills
• Conflict Management and Interpersonal Skills
• Accountability and Customer Focus
• Independent Working and Initiative
• Effective Communication and Multicultural Collaboration