Description
Astek provides IT services and consulting. The role supports a client in the life sciences industry.
Responsibilities
•Collaborate with the Product Manager to define the product vision, strategy, and roadmap, co-create the MVP scope, and plan subsequent releases
•Prioritize and develop the Product Backlog, considering business needs, technical debt, and compliance requirements
•Conduct business analysis throughout the product lifecycle
•Translate Clinical Data Management needs into product requirements, user stories, acceptance criteria, target processes, and workflows
•Define requirements for key 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 develop 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, user-centric clinical trial processes
Requirements
•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
•Strong knowledge of clinical processes and data
•Good knowledge of architecture and technologies, particularly REST APIs, microservices architecture, data integrations, 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
•Strong 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
Conditions
•Salary: up to 15,000 PLN gross/month, depending on experience and competencies
•Long-term cooperation
•Technical training, certifications, and professional development
•Mentoring, Competence Center, participation in conferences, knowledge and experience sharing
•Clear career path
•Employee benefits package (Multisport, private medical care, life insurance)
•Friendly work atmosphere, integration events and team-building meetings
•Referral system with bonus up to 7000 PLN
