Tejas P.
Junior Data Manager (Clinical Data Management)
Experience
Mar 2023 - Oct 2025
2 years 8 monthsMumbai, India
Junior Data Manager (Clinical Data Management)
Tata Consultancy Services
- Executed comprehensive data validation processes and performed manual data review across multiple global projects
- Identified, generated, and resolved discrepancies through efficient query management aligning with the Data Validation Specification (DVS)
- Performed vendor data reconciliations including SAE reconciliation and addressed inconsistencies between the clinical database and external datasets (e.g., lab and PK/PD data)
- Supported study start-up by providing DVS input, coordinating and executing User Acceptance Testing (UAT) for data entry screens and edit checks, and ensuring data dictionary quality control
- Coordinated and mentored junior team members, providing project-specific training on data management activities and SOPs
- Supported audit readiness by reviewing study files, documentation, and data listings to ensure compliance with ICH-GCP and internal SOPs
- Utilized Medidata Rave and Oracle Clinical to run data cleaning and status reports, minimizing rework by adhering to study instructions and anticipating data quality impacts
Summary
Highly competent and results-driven Clinical Data Management (CDM) professional with 2+ years of experience successfully managing complex, global clinical trials.
Expertise includes the full lifecycle of data management, from study start-up (UAT, DVS input) through conduct (Discrepancy Management, Vendor Reconciliation, Data Cleaning) and closeout (SAE Reconciliation, data delivery).
Proven ability to coordinate tasks, provide training, and ensure ICH-GCP compliance using industry-standard EDC systems like Medidata Rave and Inform EDC, Oracle Clinical.
Languages
English
AdvancedMarathi
AdvancedEducation
Dr. Rajendra Gode College of Pharmacy
Bachelor of Pharmacy · Malkapur, India
Certifications & licenses
Clinical Research Fundamentals
TCS
ICH-GCP Certification (Good Clinical Practice)
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