DEEPA PATHAPATI
Vancouver,BC
Summary
Dedicated clinical research professional with over 10 years of experience in clinical trial management, document control, and regulatory compliance across multiple therapeutic areas, including oncology, cardiology, gastroenterology, neurology, nephrology, and rare diseases. Proven expertise in Trial Master File (TMF/eTMF) management using Veeva Vault and Medidata RAVE. Certified in ICH-GCP and Good Documentation Practices (GDP), with a strong understanding of FDA and Health Canada regulatory requirements. Skilled in supporting trial start-up, maintenance, and closure while ensuring high standards of accuracy and confidentiality.
Overview
11
11
years of professional experience
6
6
years of post-secondary education
7
7
Certifications
4
4
Languages
Work History
Program Assistant
Vancouver Coastal Health
Vancouver, BC
08.2023 - Current
- Managed and processed confidential clinical data and patient records using EMR and PARIS systems
- Coordinated and scheduled patient appointments, managed referrals, and ensured timely communication with healthcare providers
- Organized and maintained clinical documentation, ensuring accuracy and regulatory compliance
- Processed data and clinical documents with proper metadata and tracked updates to maintain consistency
- Prepared program materials and coordinated meetings, recording detailed minutes and follow-ups
- Managed office operations, including tracking expenses, processing travel claims, and maintaining inventory
Clinical Document Control Specialist / ETMF Specialist
Syreon Corporation
Vancouver, BC
06.2021 - 01.2022
- Managed and maintained TMF/eTMF using Veeva Vault and Medidata RAVE across all trial phases, including oncology studies
- Captured, tracked, and organized clinical trial data, ensuring compliance with ICH-GCP and DIA reference model
- Performed quality control checks, ensuring completeness and accuracy of TMF files for audit readiness
- Developed and updated standard operating procedures (SOPs) in line with regulatory requirements
- Provided cross-functional support, tracking action items and coordinating with project teams to ensure timely resolution
- Assisted with global TMF quality and inspection readiness by monitoring metadata accuracy and document filing
Senior Clinical Trial Associate / ETMF Specialist
IQVIA
Bangalore, Karnataka
09.2014 - 12.2018
- Managed eTMF for global clinical trials, ensuring compliance with sponsor and regulatory requirements
- Supervised and trained junior staff on TMF processes, regulatory standards, and document indexing
- Ensured proper document classification, metadata accuracy, and inspection readiness
- Coordinated with trial teams to monitor project progress and ensure adherence to deadlines
- Provided status updates to trial and cross-functional teams, maintaining detailed reports and trackers
- Created and maintained clinical trial databases using CTMS, ELVIS, SharePoint, and Wingspan
- Developed and maintained country-specific regulatory trackers for global clinical trials
Clinical Trial Assistant
IQVIA
Bangalore, Karnataka
10.2013 - 06.2014
- Supported start-up, maintenance, and close-out of clinical trials, ensuring proper documentation and compliance
- Collected and organized clinical trial data, ensuring accurate data entry and metadata consistency
- Coordinated with external agencies for trial set-up and ensured adherence to protocols and timelines
- Provided administrative support, including preparing reports and organizing trial-related documents
- Tracked and reviewed trial data, comparing it with internal databases to ensure accuracy and consistency
Education
Master’s Degree - Biochemistry
Bangalore University
Bangalore 04.2010 - 12.2012
Bachelor’s Degree - Biotechnology, Botany, and Chemistry
Sri Venkateshwara University
Tirupati 03.2007 - 03.2010
Skills
- Clinical Trial Management
- TMF/eTMF
- Veeva Vault
- Medidata RAVE
- CTMS
- Regulatory Compliance
- ICH-GCP
- GDP
- FDA
- Health Canada
- DIA Reference Model
- Data Management
- EDC
- QRPM Software
- OBIA Finance Analytics
- TRIO
- Quality Control
- Inspection Readiness
- ALCOA
- SOP Adherence
- Systems Expertise
- Wingspan
- Infosario
- Project Coordination
- Patient Safety
- Confidentiality
- EMR
- Clinical Data Processing
- Administrative Support
Certification
IAOCR Accredited Professional – Trial Master File Professionals Program (TMF Immersion, TMF Discovery)
Awards
Recognized for contributing to the successful delivery of over 8000 Investigator Letters and Financial Disclosure Statements across 39 countries in a single day at IQVIA (06/01/14)
Timeline
Program Assistant
Vancouver Coastal Health
08.2023 - Current
Clinical Document Control Specialist / ETMF Specialist
Syreon Corporation
06.2021 - 01.2022
Senior Clinical Trial Associate / ETMF Specialist
IQVIA
09.2014 - 12.2018
Clinical Trial Assistant
IQVIA
10.2013 - 06.2014
Master’s Degree - Biochemistry
Bangalore University
04.2010 - 12.2012
Bachelor’s Degree - Biotechnology, Botany, and Chemistry
Sri Venkateshwara University
03.2007 - 03.2010
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