JD:

Business Analyst / Project Manager – Clinical Systems & Applications (India GCC)
IRT/RTSM | Veeva eDC/CTMS | Clinical Ink (eCOA/eConsent) | Clinical Operations | GxP Compliance
Position Summary
This role sits within Vertex's Clinical Operations / Clinical Systems organization and acts as the Business Analyst and Project Manager for clinical technology platforms supporting global clinical trials — including IRT/RTSM, Veeva eDC/eTMF/CTMS, and Clinical Ink (eCOA/eConsent). The individual will partner with Clinical Operations, Data Management, Biostatistics, and IT/Platform teams to gather requirements, manage system implementations and enhancements, and ensure clinical applications are configured, validated, and maintained in accordance with GxP and regulatory standards.
The ideal candidate combines hands-on clinical systems / clinical application management experience with solid Business Analyst and Project Management fundamentals, and is comfortable operating across study start-up, conduct, and close-out phases in a GxP-regulated, matrixed global environment.
Key Responsibilities
1.



Business Analysis & Requirements Management
• Elicit, document, and validate business and functional requirements for clinical systems (IRT, eDC, eTMF, CTMS, eCOA/eConsent) in partnership with Clinical Operations and study teams.
• Translate clinical trial protocol and operational requirements into system specifications, user stories, and configuration/build requirements.
• Author and maintain business requirements documents (BRDs), functional specifications, process flows, and traceability matrices.
• Support UAT planning and execution, defect triage, and validation that delivered functionality meets study and business intent.
2. Project Management — Clinical Systems Implementations
• Lead or support end-to-end project management for clinical system implementations, upgrades, and study-level configurations (IRT builds, eCOA/eConsent deployments, CTMS enhancements).
• Develop and ma

📌 Business Analyst (India)
🏢 Cognizant
📍 India