Nakul Phapale
Senior eTMF Specialist
- Role
- Senior Etmf Specialist at Tata Consultancy Services
- Location
- Thane, IN
- LinkedIn followers
- 500 followers
About Nakul Phapale
Experienced Trial Master File (TMF) Specialist | 4 Years in Clinical…
Experience
Senior Etmf Specialist
Jun 2024 — Present · Thane, IN
Implementation and managing electronic trial master file systems to ensure efficient & compliant document storage & retrieval. Maintain effective communication channels to update stakeholders on eTMF status, address queries, and ensure transparency in document management processes. Establish and maintain document control processes to organize, categorize, and version clinical trial documents within the eTMF. Implement measures to maintain the integrity and reliability of data within the eTMF, including routine quality checks and validation processes. Configuring workflows and permissions to streamline document review and approval processes. 6.Managing comprehensive Trial Master File (TMF) oversight across multiple clinical trials, ensuring adherence to regulatory standards and facilitating successful inspections. TMF health checks to assess document completeness, accuracy, and compliance with FDA and ICH-GCP guidelines, resulting in streamlined document management processes. 8.Working on Clinergize and site connect tool for collection of site documents and distribution of study documents to site by initiating workflows in tool.
Education
Elite Institute of pharma skills
Advanced Diploma In Clinical Research & Pharmacovigilance
2021 — 2021
B.G.P. Sahyadri Vidyalaya, Sangmaner
S.S.C
2014 — 2015
Savitribai Phule Pune University
Bachelor of Pharmacy
2017 — 2021
Shramik Junior College
H.S.C
2015 — 2017
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