Shivani Sudhakar
eTMF Specialist | PharmD
- Role
- Document Management Associate at Novotech
- Location
- Mangaluru, KA, IN
- LinkedIn followers
- 500 followers
About Shivani Sudhakar
IQVIA leverages my expertise as a Document Specialist to manage Trial Master File (TMF) documents across all levels using VeevaVault Clinical. My work focuses on maintaining compliance with ALCOA++ principles while supporting clinical trial processes with precision and dedication. Graduated from NGSM Institute of Pharmaceutical Sciences with a PharmD, I bring a foundation in pharmacy and hands-on experience as a trainee pharmacist and intern. Motivated to expand into regulatory affairs, clinical data management, and medical writing, I am committed to continuous learning and contributing to impactful projects in the clinical research domain.
Experience
Document Management Associate
Jun 2025 — Present · Bengaluru, IN
QC review of TMF documents as per ALCOA++ principles, essential documentation and GDP principles. Ensuring TMF is filed with highest quality and is always Inspection Ready (IR)
Education
St. Agnes PU College - India
PUC, PCMB
2015 — 2017
St. Agnes' Convent Higher Secondary School
Sslc
2013 — 2014
NGSM Institute of Pharmaceutical Sciences
Doctor of Pharmacy - PharmD, Pharmacy
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