Senior Clinical Business Analyst

Key Responsibilities

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

Key Requirements

Must-Have:

• 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.