Clinical Business Analyst

ITFS operates in the IT field and offers cooperation based on B2B contracts with clients in Poland.

• Minimum 3 years of experience as a Business Analyst, Requirements Engineer, Systems Analyst, or similar.
• Experience in pharmaceutical, life sciences, or other GxP-regulated environments.
• Strong knowledge of Clinical Development, Clinical Operations, or Clinical Data Management processes.
• Experience working with senior stakeholders and conducting workshops and analytical sessions.
• Experience with enterprise systems supporting clinical processes.
• Practical experience in creating, analyzing, reviewing, and remediating UERS/URS, FRS, Business Requirements, Functional Specifications, Process Flows, and Acceptance Criteria documentation.
• Experience with Requirements Traceability, including creating and maintaining a Requirements Traceability Matrix.
• Experience with UAT, solution validation, and requirements coverage mapping.
• Experience with complex enterprise application landscapes and system integrations.
• Ability to analyze incomplete or inconsistent documentation and translate it into clear requirements.
• Strong skills in requirements elicitation, analytical writing, and process modelling.
• Excellent communication, facilitation, and stakeholder management skills.
• Ability to identify and challenge inconsistencies while maintaining effective collaboration.
• Independence and capability to collaborate effectively with Business Analysis, Architecture, and Validation teams.
• Very good English language skills in speech and writing (minimum B2/C1).

Nice to have:

• Experience with Veeva Vault Clinical and multi-vault environments.
• Experience with Medidata platforms and clinical study workflows.
• Knowledge of clinical data flows to Snowflake or other data warehouses.
• Familiarity with CSV, CSA, GAMP 5, 21 CFR Part 11, or EU Annex 11 standards.
• Experience with tools such as Jira, Azure DevOps, Confluence, and requirements management tools.
• Experience in application portfolio assessment, capability mapping, or technology landscape rationalization.

• Plan and conduct discovery workshops, stakeholder interviews, and requirement review sessions in Clinical Development.
• Analyze existing documentation including UERS/URS, FRS, process documentation, project specifications, test evidence, and SDLC artifacts.
• Reconstruct end-to-end traceability from business intent through functional requirements to system capabilities, integrations, and validation evidence.
• Identify missing, duplicated, outdated, or conflicting requirements and agree on remediation priorities.
• Verify, update, and document priority business and functional requirements, business rules, process flows, user stories, and acceptance criteria.
• Map Clinical Development processes and business capabilities to supporting applications and integrations.
• Analyze dependencies among Veeva Vault, Medidata, ODR/Snowflake, and other R&D systems, identifying functional gaps and overlaps.
• Maintain requirements traceability during assessment, remediation, testing, and business acceptance.
• Support UAT preparation by defining scenarios, acceptance criteria, and mapping requirement coverage.
• Maintain registers of decisions, assumptions, issues, and dependencies, escalating matters requiring business or architectural decisions.
• Collaborate with Clinical Systems Architects and Validation/CSA specialists to ensure requirements are implementable, testable, and compliant with GxP.

Only candidates located in Poland are considered. Cooperation is based on B2B contract without paid vacations.