business analyst in clinical research

The company provides IT services and consulting. The client operates in the life science sector, focusing on clinical development, clinical data management, and clinical trial operations.

• Collaborate with the Product Manager to define the product vision, strategy, roadmap, MVP scope, and future releases;
• Prioritize and develop the Product Backlog based on business needs, technical debt, and compliance requirements;
• Lead business analysis across the full product lifecycle;
• Translate complex Clinical Data Management needs into product requirements, user stories, acceptance criteria, target processes, and workflows;
• Define requirements for platform features including AI-driven discrepancy detection, Human-in-the-Loop (HITL), automated query generation, Medidata Rave integrations, rule libraries, monitoring, governance, and GxP auditability;
• Connect business, technology, architecture, AI/ML, UX, and regulatory perspectives;
• Build and improve best practices for business analysis, requirements engineering, and documentation;
• Collaborate with Clinical Data Management SMEs, Data Science/AI, Engineering, Enterprise Architecture, Quality & Validation, and UX teams;
• Ensure effective use of AI in validated, scalable, and user-centric clinical research processes.

• 10+ Years of experience in Business Analysis, Product Analysis, Product Management, or roles combining these areas;
• At least 5 years of experience in Life Sciences, particularly Clinical Development, Clinical Data Management, or Clinical Trial Operations;
• Experience creating and developing complex, scalable enterprise digital products;
• Very good knowledge of clinical processes and data;
• Good knowledge of architecture and technologies, including REST APIs, microservices architecture, data integration, and system interoperability in cloud environments;
• Knowledge of regulatory requirements and validation processes, particularly GxP, CSV/CSA, and 21 CFR Part 11;
• Experience leading and mentoring Business Analysts;
• Ability to collaborate with senior stakeholders and influence decisions without formal authority;
• Very good communication skills and fluent written and spoken English;
• Very good knowledge of Jira, Confluence, and Agile / SAFe;
• Practical experience using GenAI / LLM tools to improve analytical work and create BA artifacts.

• Long-term cooperation;
• Technical training, certifications, and professional development;
• Competence Center mentoring, conferences, and knowledge-sharing opportunities;
• Clear career path;
• Employee benefits package including Multisport, private medical care, and life insurance;
• Friendly work atmosphere, integration events, and team-building meetings;
• Referral bonus of up to 7000 zl.