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Ramesh Roy
Senior Data Manager
Senior Data Manager
Ramesh is a Senior Data Manager with over 9 years of experience in managing clinical and external data across Phase I–III trials. He specializes in vendor/external data oversight, complex data reconciliation, and end-to-end data management operations across multiple therapeutic areas including oncology, dermatology, cardiovascular, infectious diseases, and nephrology. Bharathi excels in coordinating cross-functional teams, ensuring data quality, and streamlining processes to support on-time study delivery. Skilled in platforms such as Medidata Rave, Veeva, Viedoc, Oracle Clinical, SPOTFIRE, and CTMS/eTMF systems, she consistently drives operational efficiency while maintaining compliance with industry standards. Known for her strong stakeholder management, technical expertise, and mentoring abilities, Bharathi delivers high-quality clinical data solutions that enhance trial integrity and accelerate project outcomes.
FORMERLY AT
Senior External Data Specialist – Data Management
LOCATION
Bangalore
AVAILABILITY
Full-time
Skills
APEX
CTMS
EDM Calendar
eTMF
Laboratory Data Systems
Medidata Rave
Oracle Clinical
RTSM/EDC Systems
SPOTFIRE
SQL
Veeva
Vendor Data Platforms
Viedoc
Work Experience
Senior External Data Specialist – Data Management
Novotech, Bangalore
June 2021 – Present
- Lead external data operations for multi-therapeutic clinical trials, managing end-to-end data transfers, reconciliation, and quality processes.
- Coordinate with vendors to define requirements and ensure SOP compliance.
- Oversee unblinded data handling, access control, pharmacokinetic reporting, and implement process improvements to enhance data integrity.
- Mentor team members on CDM systems and best practices.
TECHNOLOGIES
Medidata Rave, Veeva, Viedoc, Oracle Clinical, SPOTFIRE, CTMS, eTMF, RTSM/EDC Systems
Clinical Data Management Analyst
Accenture Solutions Pvt. Ltd., Bangalore
May 2019 – June 2021
- Conducted CRF data review, cleaning, and summary report generation.
- Managed vendor queries, performed data reconciliation using Rave and Oracle Clinical, and validated study data using SQL and APEX.
- Handled data transfer scheduling through EDM calendar and ensured QC, SLA compliance, and database lock readiness.
TECHNOLOGIES
Medidata Rave, Oracle Clinical, SQL, APEX, EDM Calendar, CTMS
Data Manager I
Covance Pharmaceuticals Ltd., Bangalore
March 2018 – May 2019
- Executed data reconciliation for CRF and laboratory datasets, ensuring accuracy and completeness.
- Managed full CDM lifecycle activities, including timelines, design, and QC.
- Maintained DTAs/DTS and ensured vendor compliance.
- Oversaw blinded data cleaning activities for database lock.
TECHNOLOGIES
Oracle Clinical, Laboratory Data Systems, Vendor Data Platforms
