Link Group is seeking a highly experienced Senior Clinical Business Analyst to join our team. In this role, you will act as a bridge between Clinical Development business units and IT teams, ensuring that complex system landscapes are effectively mapped, documented, and validated to meet rigorous GxP standards.
Key responsibilities
- Lead discovery workshops and interviews to gather and refine requirements across Clinical Development business and IT teams.
- Reconstruct end-to-end traceability by linking business intent, functional requirements, and system capabilities within a Requirements Traceability Matrix.
- Evaluate and remediate UERS/URS, FRS, process flows, and user stories to resolve gaps and ensure alignment with business objectives.
- Map current-state processes and dependencies across enterprise systems including Veeva Vault, Medidata, and Snowflake-based data platforms.
- Support UAT preparation and collaborate with Validation SMEs to ensure full audit readiness under GxP standards.
Requirements
- Over 7 years of experience in Business Analysis or Systems Analysis within senior, stakeholder-facing roles.
- Deep domain expertise in Clinical Development, Clinical Operations, or Clinical Data Management processes.
- Proven track record of authoring and remediating documentation in pharmaceutical or GxP-regulated environments.
- Strong ability to navigate and analyze complex, multi-application enterprise landscapes.
- Excellent communication skills in English, with a demonstrated ability to facilitate high-level workshops.
What we offer
- Opportunity to work on high-impact projects within the life sciences and pharmaceutical sectors.
- Professional development in a collaborative environment focused on complex system integration.
- Exposure to industry-leading clinical platforms and GxP validation methodologies.