Link Group

Senior Clinical Business Analyst

130 - 150 PLN/ godz./ godz.B2BB2B (netto)

MidZdalnie·WarszawaFull-time·B2B

#453079·Dodano 18 dni temu·1

Źródło: justjoin.it

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Tech Stack / Keywords

Business AnalysisClinical DomainSystem Analysis

Podsumowanie oferty

The Senior Clinical Business Analyst will lead workshops and manage requirements traceability for Clinical Development projects. This role focuses on analyzing processes, supporting UAT and validation under GxP standards, and maintaining governance logs. The position involves working with systems such as Veeva Vault, Medidata, and Snowflake to ensure alignment and audit readiness.

Wymagania

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.

Obowiązki

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.

Inne informacje

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.

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