Pratiti Sanyal
Bengaluru
Summary
Clinical Research professional with hands-on experience supporting global Oncology and Immunology trials, specialising in clinical documentation governance, CTMS/eTMF operations, patient-data handling, and cross-functional stakeholder coordination. Skilled in maintaining TA-level trackers for disclosure deliverables, supporting transparency system updates, and driving SOP-compliant documentation to maintain audit-ready quality. Adept at managing study budgets and site payments while streamlining workflows to improve clarity, compliance and delivery timelines.
Overview
3
3
years of professional experience
Work History
Project Support Coordinator (Clinical Research)
Thermo Fisher Scientific
Bangalore
07.2024 - Current
- Supporting global clinical trials across Oncology and Immunology portfolios by ensuring documentation accuracy, data governance and sponsor compliance.
- Managing CTMS activity tracking and reporting of study metrics to support operational planning and study health oversight.
- Maintaining eTMF quality through central file reviews, defect identification and resolution tracking to ensure audit-ready documentation.
- Designed and implemented documentation checklists which reduced repetitive clarification cycles and improved file processing timelines.
- Managed study budgets and site payments for sponsor programs including Takeda, Genentech, Moderna, Roche and Argenx.
- Coordinated study launch and kickoff meetings, recorded detailed minutes and distributed communications for stakeholders.
- Supported translation QC, vendor access, CRG file maintenance and system-based communication workflows.
- Assisted ad-hoc project management tasks including tracker updates, report creation and study plan edits.
Graduate Intern Trainee, Regulatory Information Management System
GSK
01.2023 - 01.2024
- Performed indexing, quality review and regulatory data handling of submissions and correspondence in Veeva Vault.
- Supported implementation of DER (Document Execution Request) to improve document traceability and governance.
- Assisted regulatory teams in compiling FDA submissions and retrieving regulatory documentation.
Education
M.Pharm - Pharmaceutical Analysis
Manipal College of Pharmaceutical Sciences (MCOPS)
Manipal01.2024
Bachelor of Pharmacy -
Acharya & B.M. Reddy College of Pharmacy (RGUHS)
Bangalore01.2021
Skills
- Clinical Trial Transparency
- Disclosure Deliverables Support
- CTMS Tracking
- ETMF Quality Compliance
- Patient Data Handling
- Study Budget & Site Payment Tracking
- Documentation Governance
- Central File Reviews
- Investigator Grant Forecast
- Meeting Minutes Management
- Stakeholder Coordination
- Cross-functional Team Collaboration
- Process Improvement
- Veeva Vault Clinical
- Veeva Quality Suite
- Veeva Clinical CTMS
- Siebel CTMS
- ETMF
- Preclarus
- Investigator Grant Forecast Tool
- Study Inventory Tool
- MS Excel
- MS PowerPoint
- MS Outlook
- MS Word
Accomplishments
- MAHE Scholar Scholarship (2022–2023)
- All-India MET Rank: 203
- Rank Holder – RGUHS B.Pharm
- Poster Presentation – Pharma Quora 2022
Languages
- English
- Hindi
- Bengali
Personal Information
- Date of Birth: 06/29/98
- Nationality: Indian
- Marital Status: Unmarried
Timeline
Project Support Coordinator (Clinical Research)
Thermo Fisher Scientific
07.2024 - Current
Graduate Intern Trainee, Regulatory Information Management System
GSK
01.2023 - 01.2024
M.Pharm - Pharmaceutical Analysis
Manipal College of Pharmaceutical Sciences (MCOPS)
Bachelor of Pharmacy -
Acharya & B.M. Reddy College of Pharmacy (RGUHS)