A senior business analyst role focused on clinical systems in pharma/life sciences: gathering requirements from senior stakeholders and authoring validated documentation (URS/FRS, user stories, trace matrices) for GxP-regulated, multi-application enterprise landscapes. Preferred exposure to Veeva Vault Clinical, Medidata, Snowflake, Jira, Confluence, and Azure DevOps.
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.