Priya P.
Senior TMF Project Manager
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Priya P. is a highly experienced Senior Document Specialist based in Bangalore with a robust 7.4-year track record in Veeva Vault project management and TMF management, particularly within Tata Consultancy Services. She has been instrumental in reviewing and maintaining TMF documents, ensuring quality and compliance with Good Clinical Practice (GCP) standards. Priya is adept at performing specialized quality control on clinical documents and conducting thorough reviews to maintain inspection readiness. Her expertise extends to managing the completeness and quality oversight of the Trial Master File (TMF) while adhering to the DIA TMF Reference Model standards. Additionally, Priya plays a crucial role in internal training and process optimization, supporting her team in achieving higher quality standards and compliance. Her proficiency in documentation management, combined with collaborative skills with CROs and sponsors, underscores her commitment to enhancing operational efficiencies in the clinical research sector.
Experience
Senior Process associate in TMF management
Tata Consultancy Services Limited · 2018 — 2025Reviewed TMF documents and identified inconsistencies. Ensured compliance with SOPs while maintaining quality TMFs in alignment with Good Clinical Practice (GCP). Verified availability and proper filing of documents listed in the TMF Table of Contents according to trial timelines. Conducted specialized QC on essential clinical documents, reviewed assigned tasks, and communicated findings to the TMF QC Manager. Engaged in discussions regarding critical issues with the QC manager as needed. Performed daily QC activities and ongoing reviews to maintain compliance and readiness for inspection, confirming that the content accurately reflects the trial. Assisted in training and mentoring new hires and adapting to ongoing process changes. Supported internal quality control efforts to enhance the quality of processes and managed administrative tasks such as tracking attendance, errors, and updates. Conducted knowledge sharing sessions with new joiners.
Skills & Expertise
Education
- BSc DegreeRani Channamma University Belagavi
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