Ragula Ravali
Bangalore
Summary
Senior Clinical Data Manager with 6+ years of experience in Clinical Data Management (CDM) in multiple therapeutic areas. Expertise in EDC, CRF design, edit checks, UAT, SAE and vendor data reconciliation, data review, and database lock. Strong knowledge of GCP and regulatory compliance with a proven track record of delivering high-quality, inspection-ready data on time.
Overview
8
8
years of professional experience
Work History
Sr Clinical Data Coordinator at
Veranex
10.2024 - Current
- Managed end-to-end activities including database build reviews, CRF design, edit check validation, and UAT execution for high-quality EDC setup.
- Reconciliation for SAE, ePRO, lab, eCOA, and third-party data to ensure alignment with primary EDC sources.
- Drafted and reviewed Data Management Plans (DMPs) and Data Review Guidelines.
- Led data review meetings with Clinical, Safety, and Biostatistics teams, managing query workflows and medical coding reviews.
- Guided studies to successful database freeze and lock through rigorous issue tracking, discrepancy management, and timeline monitoring.
Data Manager at
Tata Consultancy Services
03.2022 - 03.2024
- Developed Data Management Plans (DMP), Quality Control (QC) plans, and eCRF completion guidelines complying with SOPs.
- Created Data Validation Specifications (DVS) for edit checks and drafted corresponding system test steps.
- Developed Data Transfer Agreements (DTAs) to define secure, standardized vendor data-sharing parameters.
- Aligned database builds and data flow structures with complex clinical protocols.
- Cleared data discrepancies within timelines by issuing and resolving queries with clinical sites.
- Ran data listing programs to evaluate patient data consistency, quality, and completeness.
- Reconciled External Data, Reviewed protocol deviations and coordinated medical coding activities with the coding team.
- Shared Rave study designs with SDTM teams to facilitate compliant dataset preparation and deliverables.Shared Rave study designs with SDTM teams to facilitate compliant dataset preparation and deliverables.
- Maintained inspection-ready study documentation and secured client approvals within the vTMF tool.
- Directed daily resource allocations, training initiatives, and task supervision for the data team.
- Database Lock, Study Closeout activities.
- Completed post-lock archival activities to guarantee compliance and long-term data preservation.
Clinical Data Analyst at
Croissance Clinical Research
01.2019 - 03.2022
- Performed systematic QC reviews and data verification to manually identify, track, and resolve discrepancies.
- Reconciliation across lab, IVRS, and ECG platforms to eliminate data mismatches against the EDC.
- Delivered critical data management deliverables on schedule by strictly adhering to project-specific guidelines.
- Provided technical input for protocol amendments and managed post-go-live eCRF modification reviews.
Education
MSC - Biotechnology
Periyar University
01-2011
B.Sc. - Biotechnology
Sri Chaitanya Degree College
01-2009
Skills
- Clinical trial expertise
- Knowledge of ICH GCP Guidelines
- Knowledge of 21CFR part 11 regulations
- Data integrity
- Protocol compliance
- Data management
- Database management
- EDC Build Oversight (Rave)
- Edit Check Specifications
- Risk-Based Data Review
- SAE Reconciliation
- Vendor Collaboration
- Cross-functional Stakeholder Coordination
- Timeline & Metrics Management
Accomplishments
- Completed 2Year project work entitled as 'High Performance Liquid Chromatography (HPLC)' under the joint guidance of Mr. Sanjeeva Reddy, Deputy Manager and Mr. Srinivas Reddy, Sr. Executive, QC Department, Dr. Reddy’s Laboratories Ltd., FTO- II, Bollaram, Hyderabad, A.P.
- Review Paper on Recent Trends in Analytical Techniques for the Development of Pharmaceutical Drugs. Published in J Bioanal Biomed; 3(3), 2011, 1-7, ISSN: 1948-593X JBABM, an open access journal.
Training
Advance Program in Clinical Research & Management, CLINI INDIA
Therapeutic Area
Immunology, Neurology, Cardiovascular Diseases, Vaccines, Ophthalmology, Dermatology
Disclaimer
I, hereby declare that the above information cited is correct and true to the best of my knowledge.
Timeline
Sr Clinical Data Coordinator at
Veranex
10.2024 - Current
Data Manager at
Tata Consultancy Services
03.2022 - 03.2024
Clinical Data Analyst at
Croissance Clinical Research
01.2019 - 03.2022
MSC - Biotechnology
Periyar University
B.Sc. - Biotechnology
Sri Chaitanya Degree College