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Kabir Kapoor
TMF Study Lead – Global Drug Development Operations
Clinical Operations
Kabir Kapoor is a clinical operations professional with 11+ years of experience in Trial Master File (TMF) management and Quality Management Systems. He has led TMF strategy and execution for 70+ global studies across Phases I–IV, ensuring regulatory compliance, inspection readiness, and process optimization. Skilled in Veeva Vault, CAPA management, CRO oversight, and enterprise-level TMF standardization, Kabir partners with cross-functional stakeholders to drive audit-ready documentation and operational excellence.
FORMERLY AT
Bristol Myers Squibb
LOCATION
Hyderabad, India
AVAILABILITY
Full Time
Skills
Audit/Inspection Readiness
CAPA
Deviation Management
MS Office 365
Risk-Based Document Review
TMF Metrics/KPIs
TMF Reconciliation
Veeva Vault (TMF/CTMS/QMS/RIM)
Work Experience
TMF Lead-II – Global Clinical Development
Fortrea (formerly Labcorp Drug Development)
May 2022 – December 2023
- Led TMF operations ensuring audit-ready documentation for multiple global studies.
- Delivered TMF health reviews, periodic reconciliation, CAPA implementation, and deviation management.
- Mentored TMF leads and standardized processes across portfolios including Roche–Genentech.
TECHNOLOGIES
TMF Reconciliation, CAPA, Deviation Management, Risk-Based Document Review
Assistant Manager – TMF Operations / Business Process Lead / Sr. Process Associate
Tata Consultancy Services (TCS)
March 2014 – May 2022
- Managed TMF operations and delivery for U.S.-based pharma clients, overseeing teams of 100+ members.
- Led audits, stakeholder communications, KPI tracking, and UAT for system enhancements. Drove Six Sigma and automation initiatives improving efficiency and TMF quality.
- Awarded “Contextual Master” and multiple Star Performer recognitions
TECHNOLOGIES
Veeva Vault, Six Sigma (Lean), Spotfire, Power Automate, SharePoint, Automation (VBA)
