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 strong 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 manage project plans, timelines, RAID logs,



and status reporting across cross-functional and vendor stakeholders.
- Coordinate study start-up activities related to clinical technology set-up, ensuring systems are ready ahead of first-patient-in (FPI) milestones.
- Manage vendor relationships and deliverables for clinical system providers, ensuring adherence to timelines, quality, and contractual scope.

3. Clinical Application Management & Operations

- Provide ongoing application management support for IRT, Veeva CTMS/eDC/eTMF, and Clinical Ink platforms — including issue triage, enhancement requests, and release coordination.
- Maintain system configuration documentation, SOPs, and user guidance for supported clinical applications.
- Support system integrations across the clinical technology ecosystem (IRT, EDC, eTMF, CTMS, safety systems) to ensure data consistency and process alignment.
- Monitor system performance and user adoption; recommend and implement continuous improvement initiatives.

4. GxP Compliance & Validation

- Ensure clinical systems and associated processes comply with GxP, 21 CFR Part 11, and applicable global regulatory requirements.
- Support computer system validation (CSV) activities - validation plans, test scripts, traceability documentation — for recent implementations and system changes.
- Maintain audit-ready documentation and support internal/external audits and regulatory inspections related to clinical systems.
- Partner with Quality and Regulatory teams to assess change impact and ensure compliant change control practices.

5. Stakeholder Management & Cross-Functional Partnership

- Act as a trusted liaison between Clinical Operations, Data Management, Biostatistics, IT/Platform teams, and external vendors.
- Facilitate working sessions and governance forums to align on requirements, priorities, risks, and dependencies.
- Represent the clinical systems perspective in global forums, ensuring study and operational needs are reflected in platform roadmaps.
- Provide regular status updates and escalate risks/issues to Clinical Operations and Clinical Systems leadership as needed.

📌 Business Analyst / Project Manager – Clinical Systems & Applications- Vertex (India)
🏢 Cognizant
📍 India