Link Group

Senior Clinical Business Analyst

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

SeniorZdalnieFull-time·B2B

#452779·Dodano 28 dni temu·1

Źródło: nofluffjobs.com

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Tech Stack / Keywords

Business analysisData managementVaultGXPJira ConfluenceAzure DevOps

Podsumowanie oferty

This role involves senior-level business analysis focused on Clinical Development, Clinical Operations, or Clinical Data Management processes. The analyst will work across complex, integrated enterprise landscapes in GxP-regulated environments. Key responsibilities include leading discovery workshops, managing requirements traceability, and supporting UAT and validation efforts. Strong communication and facilitation skills in English are required.

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.
Experience 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 linking business intent, functional requirements, system capabilities, and GxP validation evidence.
Evaluate and remediate UERS/URS, FRS, process flows, user stories, and acceptance criteria, resolving gaps and overlaps.
Map current-state processes and capabilities across Veeva Vault Clinical, Medidata, Snowflake, and adjacent R&D systems.
Support UAT preparation including scenario definition and coverage mapping.
Collaborate with Validation/CSA SMEs to ensure audit readiness under GxP standards.
Maintain decision, assumption, risk, and dependency logs.
Provide business analysis inputs toward application rationalization.

Link Group

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