Product Owner - Life Science

Job Description

Key Responsibilities
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 as 21 CFR Part 11, HIPAA, GDPR, and GCP (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: Bachelor’s or Master’s degree in Biomedical 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 like HL7 or FHIR.
Certifications: Often requires or prefers Certified Scrum Product Owner (CSPO) or SAFe POPM

Mandatory Competencies