Senior Clinical Business Analyst
New
L
Link GroupClinical development
Workplace type: remote; Country code: PLContractSenior
Salary130 - 150 PLN per hour net b2b
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Job Details
- Languages
- Excellent written and spoken English
- Experience
- 7+ years of experience in Business Analysis, Requirements Engineering, or Systems Analysis in senior stakeholder-facing roles.
- Required Skills
- Business Analysis
Requirements
- Have 7+ years of experience in Business Analysis, Requirements Engineering, or Systems Analysis in senior stakeholder-facing roles.
- Bring in-depth knowledge of Clinical Development, Clinical Operations, or Clinical Data Management processes and enterprise systems.
- Have hands-on experience authoring or remediating UERS/URS, FRS, user stories, and trace matrices.
- Have experience in pharmaceutical, life sciences, or GxP-regulated environments.
- Demonstrate experience working across multi-application, highly integrated enterprise landscapes.
- Have excellent written and spoken English.
- Bring strong facilitation skills.
- Veeva Vault Clinical applications, including multi-vault environments, or Medidata platform experience is preferred.
- Understanding of clinical data flows into Snowflake-based data platforms or ODR is preferred.
- Familiarity with GAMP 5, 21 CFR Part 11, EU Annex 11, or CSA principles is preferred.
- Proficiency with Jira, Confluence, Azure DevOps, or formal requirements repositories is preferred.
Responsibilities
- 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.
- Resolve gaps, overlaps, and obsolete requirements in documentation and processes.
- Map current-state processes and capabilities across Veeva Vault, Medidata, ODR/Snowflake, and adjacent R&D systems.
- Support UAT preparation through scenario definition and coverage mapping.
- Collaborate with Validation/CSA SMEs to support audit readiness under GxP standards.
- Maintain decision, assumption, risk, and dependency logs, and provide business analysis input toward application rationalization.
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