Shivani Sudhakar
Document Management Associate @Novotech
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WORK HISTORY
Document Management Associate @Novotech
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
St. Agnes' Convent Higher Secondary School
Sslc
NGSM Institute of Pharmaceutical Sciences
Doctor of Pharmacy - PharmD, Pharmacy
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.
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