Priti Patil
@pritipatil
I maintain inspection-ready clinical trial documentation and eTMFs in Veeva Vault.
What I'm looking for
At Tata Consultancy Services, I manage electronic Trial Master Files in Veeva Vault, performing document QC, completeness reviews, co-dependency checks, metadata verification, and query resolution to keep clinical trial documentation inspection-ready.
Previously at Raptim Research, I reviewed eTMF documents, protocols, and reports while supporting audits, reconciliations, and sponsor requests. I also train team members, monitor TMF health metrics, and apply ICH-GCP, GLP, ALCOA+, and GxP standards to maintain accurate, compliant records.
Experience
Work history, roles, and key accomplishments
Managed and maintained the electronic Trial Master File (eTMF) in Veeva Vault, ensuring compliance with ICH-GCP, ALCOA+, GxP, and regulatory requirements. Performed TMF document QC reviews, co-dependency checks, and completeness reviews against the Expected Document List (EDL).
Quality Control Document Officer
Raptim Research Pvt. Ltd.
Jul 2021 - Sep 2023 (2 years 2 months)
Reviewed eTMF documents, study protocols, and supporting clinical trial documentation for accuracy, completeness, and compliance. Performed document QC and metadata checks, supported TMF completeness and inspection-readiness activities, and assisted in responding to sponsor queries.
Project Trainee
Raptim Research Pvt. Ltd.
Jan 2021 - Jun 2021 (5 months)
Assisted in developing and validating methods to enhance laboratory procedures. Calibrated analytical instruments and performed sample processing and analysis using analytical instruments.
Education
Degrees, certifications, and relevant coursework
Amity University, Mumbai
Master of Science, Biotechnology
Master of Science in Biotechnology from Amity University, Mumbai, completed in October 2021.
B.K. Birla College, Mumbai
Bachelor of Science, Microbiology
Bachelor of Science in Microbiology from B.K. Birla College, Mumbai, completed in April 2019.
Availability
Location
Authorized to work in
Job categories
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