Senior Clinical Business Analyst

Link Group is recruiting for a Senior Clinical Business Analyst to work with Clinical Development business and IT teams across multiple Polish cities, including remote work options.

• 7+ years of experience in Business Analysis, Requirements Engineering, or Systems Analysis in senior stakeholder-facing roles.
• In-depth knowledge of Clinical Development, Clinical Operations, or Clinical Data Management processes and enterprise systems.
• Hands-on experience authoring/remediating UERS/URS, FRS, user stories, and trace matrices in pharmaceutical, life sciences, or GxP-regulated environments.
• Demonstrated track record working across multi-application, highly integrated enterprise landscapes.
• Excellent written and spoken English with top-tier facilitation skills.

Nice to have:

• Hands-on experience with Veeva Vault Clinical applications (multi-vault environments) or Medidata platforms.
• Understanding of clinical data flows into Snowflake-based data platforms / ODR.
• Familiarity with GxP validation standards (GAMP 5, 21 CFR Part 11, EU Annex 11, CSA principles).
• Proficiency with Jira, Confluence, Azure DevOps, or formal requirements repositories.

• Lead discovery workshops, interviews, and review sessions across Clinical Development business and IT teams.
• Reconstruct end-to-end traceability (Requirements Traceability Matrix) linking business intent, functional requirements, system capabilities, and GxP validation evidence.
• Evaluate and remediate UERS/URS, FRS, process flows, user stories, and acceptance criteria while resolving gaps, overlaps, or obsolete requirements.
• Map current-state processes and capabilities across Veeva Vault, Medidata, ODR/Snowflake, and adjacent R&D systems.
• Support UAT preparation (scenario definition, coverage mapping) and collaborate with Validation/CSA SMEs to ensure audit readiness under GxP standards.
• Maintain decision, assumption, risk, and dependency logs while providing BA inputs toward application rationalization.

Treść obowiązku informacyjnego z art. 13 RODO dla kandydatów biorących udział w rekrutacji oraz informacje o przetwarzaniu danych osobowych zgodnie z RODO i Kodeksem pracy.