Lokesh L H
eTMF Specialist | IQVIA | Navodayan | GPAT Qualified | NIPER Qualified | Manipal Entrance Test AIR 27 |
- Role
- Document Specialist (Etmf) at IQVIA
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Lokesh L H
I am a detail-oriented Clinical Document & eTMF Specialist with one year of experience at…
Experience
Document Specialist (Etmf)
Dec 2024 — Present
As an eTMF Specialist, I bring hands-on experience in managing and maintaining Trial Master File (TMF) systems with a focus on compliance, accuracy, and inspection readiness. Skilled in using leading eTMF platforms such as Veeva Vault and Wingspan, I ensure that clinical trial documentation is complete, audit-ready, and aligned with regulatory requirements (ICH-GCP, FDA, EMA).I collaborate with cross-functional teams including CRAs, CTAs, and regulatory teams to support the smooth execution of clinical trials. My role involves:Managing TMF setup, document collection, QC, and filing.Conducting periodic quality checks to ensure inspection-readiness.Supporting study teams with TMF training and guidance.Contributing to process improvement initiatives for efficient TMF operations.Passionate about clinical research and documentation excellence, I thrive in fast-paced, global trial environments and contribute to the success of clinical studies by ensuring timely and compliant documentation.
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