Vikas Suradkar
TMF Specialist And Clinical Operations Lead
Thane
Summary
Clinical Operations and Trial Master File (TMF) Specialist with 6+ years of experience in global clinical trial documentation, TMF oversight, quality control, and Veeva Vault systems. Proven expertise in TMF health checks, Recognized as a Subject Matter Expert (SME) and trainer for Veeva Vault Clinical and Site Connect platforms, supporting process excellence and regulatory compliance across multiple studies.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Operations & TMF Specialist
Tata Consultancy Services (TCS)
12.2019 - Current
- Lead end-to-end Trial Master File (TMF) oversight for global clinical trials across multiple phases
- Generate and present TMF health check metrics and status reports during trial oversight meetings
- Ensure completeness, quality, and timeliness of TMF documents in Veeva Vault Clinical
- Perform Quality Control (QC) review of trial documentation in compliance with ICH-GCP and ALCOA principles
- Identify TMF quality issues and collaborate with Clinical Trial Managers (CTMs), CTAs, and study teams for resolution
- Act as Subject Matter Expert (SME) for Veeva Vault Clinical and Site Connect (One Medicine Platform)
- Conduct process and system training sessions for new hires and experienced associates
- Support creation and maintenance of List of Expected Records (LOER) at trial, country, and site level
- Contribute to inspection readiness activities and regulatory documentation compliance
- Manage trial and site regulatory document collection, review, and tracking throughout study lifecycle
- Initiate and manage document workflows using CTMS and Clinergize systems
- Coordinate with global IT teams for document corrections, obsoleting, or removal of sensitive records
- Support continuous process improvement initiatives and system enhancement proposals
ICSR Case Processor - Pharmacovigilance
Roche (via TCS)
12.2019 - 06.2020
- Processed Individual Case Safety Reports (ICSRs) in compliance with global pharmacovigilance regulations
- Performed data entry, medical coding, and case narrative review
- Ensured adherence to timelines and quality standards for adverse event reporting
Education
Bachelor of Pharmacy - undefined
SGBAU University
Maharashtra01.2019
Skills
Trial Master File (TMF) Management
Veeva Vault Clinical & Site Connect
TMF Health Checks & Inspection Readiness
ICH-GCP (E6) & ALCOA Principles
Quality Control Review (QC)
Clinical Trial Documentation
List of Expected Records (LOER) Management
Cross-functional Stakeholder Collaboration
Process Training & SME Support
Regulatory Documentation Compliance
Veeva Vault Clinical
Veeva Vault Site Connect
Clinical Trial Management Systems (CTMS)
Clinergize
RIMS (Regulatory Information Management Systems)
Microsoft Office Suite
Strong stakeholder communication and coordination
Conflict management and prioritization
Ability to manage multiple studies simultaneously
Team leadership and training capabilities
Detail-oriented with strong documentation practices
Certifications And Professional Training
- ICH-GCP (E6) Guidelines
- TMF Documentation & Regulatory Compliance
- Clinical Trial Documentation Management
Awards
- Star of the Quarter Award (2 times)
- Star of the Month Award (5 times)
- On-the-Spot Awards (3 times)
- Context Master Award
- Best Counterpart & Go-To Person Recognition
Personal data processing
I do hereby declare that all the information furnished above is true to the best of my knowledge and belief.
Certification
Certified trainer Veeva vault and site connect
Timeline
Clinical Operations & TMF Specialist
Tata Consultancy Services (TCS)
12.2019 - Current
ICSR Case Processor - Pharmacovigilance
Roche (via TCS)
12.2019 - 06.2020
Bachelor of Pharmacy - undefined
SGBAU University