Job Description

Senior Associate, Clinical Research

Responsibilities include, but are not limited to:
• Trial and site administration:

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

• Document management:

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

• Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:
o In a timely manner,



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

• Budgeting, Agreement and Payments:
Collaborate with finance/budgeting representatives for:
o Develop, control, update and close-out country and site budgets (including Split site
budget)
o Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
o Track and report contract negotiations
o Update and maintain contract templates (in cooperation with Legal Department)
o Calculate and execute payments (to investigators, vendors, grants)
o Ensure adherence to financial and compliance procedures
o Monitor and track adherence and disclosures
o Maintain tracking tools
o Obtain

📌 Senior Associate, Clinical Research (Gurugram)
🏢 Msd
📍 Gurugram