Shashikant Patil
eTMF Reviewer II / Subject Matter Expert (SME) / 8 + years in Clinical Operation / 5 + eTMF Management / Veeva Vault / TMF Completeness and Compliance / Periodic review
- Role
- Tmf Reviewer Ii at Fortrea
- Location
- Nashik, MH, IN
- LinkedIn followers
- 500 followers
About Shashikant Patil
I have overall 8 + years of experience in Clinical Operation. Among that I have 5 + year…
Experience
Tmf Reviewer Ii
Aug 2022 — Present · Bengaluru, IN
Managing electronic Trial Master Files (eTMF),(Trial, Country and Site artifacts) for clinical studies in accordance with TMF processes, working with key study personnel such as the Study Team Member- Tracking all trip reports within the Veeva and CTMS- Review and respond to TMF content quality issues and identifies trends per study and across programs, alerts management of trends- Prepares the TMF for QA or Sponsor audits, the resolution with identifying and implementing corrective actions to findings in audit reports- Initiating the What’s Missing for all documents and ensuring full completeness of the TMF for each study, tracking and obtaining missing, incomplete, incorrect, inaccurate artifacts against the TMF Plan and Index, and study milestones- Responsible for performing TMF review. TMF Reviewers may include, but are not limited to, Project Team members, members of Global Quality Control and other reviewers (e.g. Central TMF Reviewers)- Provide training to new joiners, help them to understand the process. Mentoring the new joiners by resolving their queries and shadowing- Performing Audit Ready Checks on individual documents uploaded in the eTMF system for every study, ensuring context is accurate.
Education
Kalyani Charitable Trusts Ravindra Gambhirrao Sapkal Pharmacy College, Sapkal PharmacyCollege, Ajneri, Wadholi, Tryambak, Dist.Nashik
Bachelor of Pharmacy - BPharm, Pharmacy
2009 — 2012
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