Are you an experienced professional in clinical research documentation or Trial Master File (TMF) management? Here’s your opportunity to join a leading global organization as a Senior TMF Associate in Mumbai (Remote). This role offers a chance to ensure regulatory compliance, audit readiness, and seamless documentation for clinical studies.
If you have 3–6 years of experience in clinical research, GCP, and ICH compliance, this is the perfect position to advance your career in the pharmaceutical and life sciences industry.
🔹 Job Overview
The Senior TMF Associate will manage document classification, audit-ready file organization, and TMF maintenance across multiple clinical studies. You will collaborate with global study teams to ensure document integrity and regulatory compliance within eTMF systems.
🧾 Key Responsibilities
- Manage electronic Trial Master Files (eTMF) across trial, country, and site levels.
- Perform document classification, ARC reviews, and deletions under Smart Inbox.
- Ensure TMF audit readiness through visual quality checks and accuracy verification.
- Conduct Audit Ready Checks and resolve discrepancies in uploaded documents.
- Maintain compliance with GCP, ICH, and SOPs during all study phases.
- Prepare TMF for QA and sponsor audits; assist in resolving audit findings.
- Collaborate with internal BP&S teams to maintain client satisfaction.
- Participate in business improvement initiatives to boost quality and productivity.
- Train and mentor junior team members as needed.
- Attend internal or external study meetings as required.
🎓 Qualifications
Minimum Requirements:
- Bachelor’s degree in Life Sciences or Business.
- 3–6 years of experience in clinical research or TMF operations.
- Strong understanding of GCP and ICH guidelines.
- Proficiency in Microsoft Office, Adobe Acrobat, and web-based tools.
- Excellent communication and organizational skills.
Preferred Qualifications:
- Master’s degree in Life Sciences or Business.
- Prior experience using clinical electronic systems (e.g., Veeva Vault, eTMF).
- Experience mentoring or training team members.
💼 Why Join
- 100% Remote Work flexibility (based in Mumbai).
- Opportunity to work on global clinical trials.
- Exposure to advanced electronic document management systems.
- Competitive salary and performance-based incentives.
- Collaborative and compliance-driven work culture.
📩 How to Apply
Application Link
