Mitali B.
eTMF Operations Analyst at Bristol Myers Squibb
- Role
- Etmf Operations Analyst at 百时美施贵宝
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Mitali B.
Clinical Research professional with 6+ years of experience in Trial Master File (TMF) management, with strong hands-on involvement in the operational execution of eTMF quality review, indexing BOT operations, and maintaining continuous TMF inspection readiness in compliance with ICH-GCP and global regulatory standards. Experienced across the full TMF lifecycle including document quality review, reconciliation, metadata governance, audit and inspection support, and process optimization, along with scripting and executing UAT for Veeva Vault eTMF releases to ensure system enhancements meet business, quality, and compliance expectations. A collaborative team player with the ability to mentor and support new hires, recognized for exceptional organizational skills, a proactive and detail-driven approach, strong stakeholder collaboration, risk-based thinking, and consistent delivery of high-quality outcomes in fast-paced clinical research environments.
Experience
Etmf Operations Analyst
Mar 2025 — Present · Hyderabad, IN
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