Vishal Saindane
eTMF| Clinical Document Specialist - I
- Role
- Etmf Clinical Documentation Specialist -i at TransPerfect
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Vishal Saindane
Responsible for Trial Master File (TMF) management and quality review of clinical trial…
Experience
Etmf Clinical Documentation Specialist -i
Sep 2022 — Present · Pune, IN
Maintained and managed the electronic Trial Master File (eTMF) system in compliance with ICH-GCP, 21 CFR Part 11, and sponsor requirements.• Ensured timely, accurate, and complete upload of essential trial documents throughout all phases of clinical trials.• Collaborated with clinical operations, regulatory, QA, and sponsor teams to verify document quality, metadata accuracy, and filing compliance.• Conducted eTMF quality control (QC) checks, performed document reconciliation, and ensured readiness for audits and inspections.• Tracked and reported eTMF completeness metrics, including milestones like Site Initiation, Enrollment, and Study Close-out.• Assisted in training cross-functional teams on eTMF processes, document naming conventions, and filing best practices.
Education
Kavayitri Bahinabai Chaudhari North Maharashtra University, Jalgaon
Bachelor of Pharmacy - BPharm
2017 — 2021
Clariwell global service Pune
PGDM
2021 — 2022
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