Mayur R. Thakare
Clinical Trial & Document Management Associate @Novotech | eTMF Reviewer | Site Operation | Clinical Operation | Trial Interactive | Veeva Vault | Regulatory Compliance | Audit Readiness
- Role
- Clinical Trial & Document Management Associate (Clinical Operation) at Novotech
- Location
- Nashik, MH, IN
- LinkedIn followers
- 500 followers
About Mayur R. Thakare
An accomplished clinical research professional with over 4.5+ years of experience in the…
Experience
Clinical Trial & Document Management Associate (Clinical Operation)
Nov 2022 — Present
On time quality review of all documents that are uploaded in the eTMF by the document owners.> Issuing of quality issues in the system for the documents that cannot be approved within the timelines.> Follow up on the replies and review of the open quality issues in order to ensure that they are resolved according to the timelines> Approve documents that have passed the quality check.>Assist CRAs/IHCRAs and PM with preparation, handling and distribution of Paper TMF & eTMF.> Perform Inspection Readiness checks according to the timelines, Quality Issues and Follow up on their resolution.> Support the eTMF Manager & Project Manager with audits and / or inspections.> Ensure that the Key Performance Indicators relevant to the eTMF are met> Manage/create/contribute documentation related to a clinical study.>Hands on all the Documents in ISF/TMF> Responsible to transform pTMF to eTMF.> Responsible to transfer CRO\'s eTMF to Sponsor’s eTMF and vice versa.> Supports eTMF Manager in communicating any recurrent issues that are identified in order for root cause analysis and action plan to be created.
Education
Confianza Clinpharm & Noble Institute Of Clinical Research , Pharmacovigillance & Data Management
Advanced Postgraduate Diploma , Clinical Research & Data Management & Pharmacovigillance
Savitribai Phule Pune University
Bachelor of Pharmacy - B.Pharm, Pharmacy, Pharmaceutical Sciences, and Administration
2016 — 2020
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.