Product Owner - Life Science @ Iris Software

• Product Vision & Strategy:Define the product''s direction, aligning platform features with business goals, market needs, and regulatory changes (e.g., data privacy, GxP).
• Backlog Management:Own, prioritize, and refine the product backlog (Epics, User Stories, Acceptance Criteria) for features in systems like CTMS, eTMF, SSU.Stakeholder Collaboration:Act as the voice of the customer, gathering requirements and feedback from Clinical Ops, Regulatory, QA, IT, UX, and Sales.
• Agile Execution:Lead sprint planning, grooming, reviews, and retrospectives, providing clarity to development teams.
• Requirements Definition:Translate complex clinical business needs into actionable technical requirements and user stories for engineering.
• Regulatory Compliance:Ensure the platform adheres to industry standards such as21 CFR Part 11,HIPAA,GDPR, andGCP(Good Clinical Practice).
• User Enablement:Drive user adoption through training, documentation, and feedback loops.

Essential Skills & Qualifications

• Experience in Product Ownership within the life sciences, healthcare, or AdTech/MarTech space.
• Deep understanding of clinical trial processes, EMR/EHR systems, or related platforms (CTMS, eTMF).
• Proficiency with Agile/Scrum methodologies.Strong analytical, communication, and problem-solving skills.
• Knowledge of regulatory compliance (GxP, Part 11) is often required.

Key Qualifications

Education:

• Bachelors or Masters degree inBiomedical Engineering,Informatics,Computer Science, or a related STEM field.Domain Expertise:Strong understanding of clinical trial phases, Electronic Data Capture (EDC) systems, or Clinical Trial Management Systems (CTMS).

Technical Skills:

• Proficiency in Agile tools (Jira, Azure DevOps) and familiarity with healthcare data standards likeHL7orFHIR.
• Certifications:Often requires or prefers
• Certified Scrum Product Owner (CSPO)orSAFe POPM

• Tech - Agile Methodology
• Development Tools and Management - Development Tools and Management - JIRA
• DevOps/Configuration Mgmt - Cloud Platforms - Azure
• Beh - Communication and collaboration