Neha Sinha
TMF Study Lead @ Bristol Myers Squibb | TMF Subject Matter Expert | Inspection Readiness Expert | Veeva Vault | ICH-GCP | FDA • MHRA • Swiss Medic | 10+ Years in Clinical Trial Documentation
- Role
- Tmf Study Lead at Bristol Myers Squibb
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Neha Sinha
Global TMF leader with 10+ years driving TMF governance, inspection readiness, and ICH-GCP compliance across complex, multi-country clinical trials (Sponsor + CRO). I partner with Clinical Operations, Quality, Regulatory, and CRO/vendor teams to keep TMFs complete, accurate, and inspection-ready throughout the study lifecycle.What I deliver:Global TMF Governance: study TMF plans, study-specific TMF lists, expected document lists, clear oversight and accountability across functionsInspection Readiness: FDA · MHRA · Swiss Medic audit/inspection support; gap assessments, remediation tracking, and “inspection story” readinessVeeva Vault eTMF Expertise: setup/structure, TMF health metrics, process optimization, and user enablementQuality & Compliance: risk-based TMF reviews, QC, audit trail rigor, CAPA support, SOP/WI improvementsTeam Leadership & Influence:Led and coached 80+ cross-functional team members across geographies, building a strong quality culture and consistent ways of workingDelivered onboarding, training, and re-training to strengthen TMF behaviors and reduce recurring findingsStrong stakeholder leadership, aligning study teams, functional owners, and vendors to timelines, quality standards, and inspection expectationsProactive issue escalation and resolution to protect TMF health and inspection outcomesI focus on building scalable TMF operating models that enhance quality, transparency, and continuous inspection readiness.
Experience
Tmf Study Lead
Oct 2023 — Present
Education
Kendriya Vidyalaya
Higher school, Science
2011
Jaywant Shikshan Prarsark Mandals Rajarshi Shahu College of Education Pune
Bachelor of Pharmacy - B Pharm, Pharmacy
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.