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Senior Clinical Business Analyst

Link Group Zobacz wszystkie oferty

Białystok

Szczecin

Poznań

Łódź

16 dni temu

W skrócie

Senior Clinical Business Analyst sought for Link Group in Białystok. Responsibilities include leading discovery workshops, reconstructing traceability matrices, analyzing/remediating requirements, mapping system landscapes (Veeva Vault, Medidata, Snowflake), and supporting UAT/validation under GxP. Requires 7+ years of BA experience in clinical development and GxP environments.

Słowa kluczowe

business analysis requirements engineering GxP validation Veeva Vault Medidata traceability matrix clinical development clinical operations data management

Skrót przygotowany przez AI na podstawie treści ogłoszenia.

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.