G. Vinod
R&D TMF Integration Lead | Global eTMF Oversight | Inspection Readiness | Veeva Vault | Open to EU, UK & Singapore Roles
- Role
- R & d Tmf Integration Lead at Sanofi
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About G. Vinod
I am an R&D TMF Integration Lead with 6+ years of global experience across pharma and CRO environments, supporting end-to-end Trial Master File (TMF) and eTMF operations for clinical trials.Currently at Sanofi, I lead TMF integration activities for outsourced studies, acquisitions, and out-licensing programs, ensuring ICH-GCP compliance, inspection readiness, and high TMF quality standards. I work closely with Clinical Operations, Digital/ITS teams, and external CRO partners to optimize TMF processes, systems, and governance models.My expertise spans TMF oversight, integration and transfers, Independent Quality Control (IQC), process improvement, and audit/inspection support across Phase studies. I have hands-on experience with Veeva Vault eTMF and Vault RIM, along with strong exposure to global TMF standards, ALCOA+ principles, and regulatory expectations.Previously, I supported global clinical trials at ICON plc and Accenture, where I gained deep experience in TMF quality control, document indexing, metadata accuracy, and inspection readiness activities across multiple sponsors and study models.I am passionate about building inspection-ready TMFs, improving operational efficiency, and enabling successful regulatory outcomes through strong collaboration and process excellence. Core Skills:TMF Integration & Transfers | eTMF Oversight | Inspection Readiness | TMF Quality Control | Veeva Vault | ICH-GCP | Global Stakeholder Management Open to relocation and international opportunities across Europe, UK, Singapore, and Canada. Open to discussions for TMF Lead / TMF Manager / eTMF Integration roles with global organizations.
Experience
R & d Tmf Integration Lead
Oct 2025 — Present · Hyderabad, IN
Lead end-to-end TMF integration activities for outsourced clinical studies, acquisitions, and out-licensing programs, ensuring ICH-GCP compliance and inspection readiness.Act as the primary point of contact for TMF integration across assigned global programs.Collaborate with Clinical Operations, Digital/ITS teams, and CRO partners to optimize TMF processes and systems.Drive process improvement initiatives to enhance TMF quality, efficiency, and governance.Support audit and inspection readiness activities through high-quality TMF oversight.Sanofi
Education
Clini India
Advanced Post Graduate Program in Clinical Research and Management
2020 — 2021
Raos Junior College
Intermidiate
2013 — 2015
Pondicherry University
Master of Business Administration - MBA
2021 — 2023
The Gelevi's Venkateshwara Vidyalaya
SSC
2012 — 2013
Karunya University
Bachelor of Technology
2015 — 2019
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