Senior Clinical Business Analyst

• Experience: 7+ years of experience in Business Analysis, Requirements Engineering, or Systems Analysis in senior stakeholder-facing roles.
• Clinical Domain Expertise: In-depth knowledge of Clinical Development, Clinical Operations, or Clinical Data Management processes and enterprise systems.
• GxP & Validation: Hands-on experience authoring/remediating UERS/URS, FRS, user stories, and trace matrices in pharmaceutical, life sciences, or GxP-regulated environments.
• Complex Landscapes: Demonstrated track record working across multi-application, highly integrated enterprise landscapes.
• Communication: 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.