Product Owner - Clinical Systems

Job Overview: We are looking for a dynamic Product Owner to lead the translation of clinical operations needs and opportunities into innovative digital products and capabilities. The Product Owner will partner with clinical operations stakeholders, end users, Product Management, and technology teams to understand business problems, envision future-state solutions, design product functionality and workflows, and translate validated concepts into actionable requirements and delivery priorities. The role will take an active, hands-on approach to product discovery and design, including developing mock-ups, prototypes, and proofs of concept to explore ideas, demonstrate proposed functionality, and obtain rapid user feedback. The Product Owner will own and prioritize the product backlog, provide ongoing direction and context to Agile development teams, and ensure delivered solutions achieve their intended user, business, quality, and compliance outcomes. Reporting to the Executive Director - Clinical Technology Platforms, the Product Owner will play a key role in shaping leading-edge digital solutions that improve study monitoring and enable the clinical trials of the future. 

Summary of Responsibilities:

• Partner with clinical operations stakeholders and end users to understand business needs, operational challenges, user workflows, and opportunities for technology-enabled improvement.
•  Help shape the product vision and define the future-state user experience, capabilities, workflows, and functionality required to achieve desired business outcomes. Lead product discovery activities, including stakeholder interviews, workflow analysis, design sessions, and evaluation of potential solution approaches. 
• Translate business problems and ideas into product concepts, functional designs, process flows, mock-ups, prototypes, and other artifacts that enable stakeholders to visualize and validate proposed solutions. 
• Rapidly develop or coordinate prototypes and proofs of concept using appropriate technologies, including low-code, no-code, and AI-assisted development tools, to test ideas and accelerate product discovery. Conduct product demonstrations with business stakeholders, end users, and leadership to communicate product concepts, demonstrate evolving functionality, gather feedback, and refine product direction. 
• Collaborate with Product Management to establish product objectives, roadmaps, priorities, and measurable outcomes. 
• Translate validated product concepts and business needs into clearly defined features, user stories, acceptance criteria, and enabling capabilities. Define, prioritize, and continuously refine the product backlog based on business value, user needs, regulatory requirements, technical considerations, and product strategy. 
• Ensure backlog items provide Agile Teams with sufficient business context, functional clarity, and acceptance criteria to enable effective solution development. 
• Make day-to-day product decisions and clarify intended functionality, workflows, and user experience throughout the development lifecycle. Balance new capabilities, enhancements, technical needs, defects, compliance requirements, and other priorities when managing the product backlog.
•  Serve as the primary connection between clinical stakeholders, Product Management, and technology delivery teams. 
• Actively participate in PI Planning and other Agile planning activities to establish priorities, dependencies, risks, and delivery objectives. Collaborate closely with Agile Teams throughout design, development, testing, validation, and release. 
• Review evolving solutions and provide timely product decisions and feedback to ensure development remains aligned with the intended product experience. Evaluate completed functionality through demonstrations and acceptance activities to ensure it meets the intended business requirements, user experience, and acceptance criteria. Ensure applicable regulatory, quality, security, privacy, and clinical-system requirements are incorporated into product design and delivery, including GxP and 21 CFR Part 11 requirements where applicable. 
• Act as the voice of the customer throughout product discovery, design, development, and delivery. Build strong working relationships with clinical research associates, centralized monitors, study teams, project leaders, regulatory stakeholders, and other product users. 
• Communicate product direction, priorities, progress, risks, dependencies, and key decisions to stakeholders and leadership. Support pilots, demonstrations, user testing, launch readiness, and adoption activities for new product capabilities. Gather user feedback and product-performance insights following release and use them to inform future enhancements and backlog priorities.
•  Identify opportunities to simplify clinical workflows, improve user experience, increase quality and consistency, and introduce innovative capabilities including automation, analytics, and artificial intelligence. Contribute to strategic planning for new clinical technology products and capabilities addressing emerging business needs.

 Qualifications (Minimum Required): 

• Bachelor's degree in Life Sciences, Information Technology, Computer Science, Business, or a related field. Advanced degree preferred. 
• Strong understanding of product management and product development practices, including product discovery, requirements definition, functional design, prototyping, iterative development, and user validation. 
• Strong knowledge of clinical operations, particularly clinical trial monitoring roles, processes, workflows, and technology needs. 
• Experience translating complex business problems into product concepts, workflows, functional requirements, user stories, and acceptance criteria. 
• Ability to develop or facilitate mock-ups, prototypes, and proofs of concept and use them effectively to communicate ideas and obtain stakeholder feedback. Comfort using modern prototyping, low-code, no-code, and AI-assisted tools to rapidly explore and demonstrate product concepts.
•  Expertise in Agile development methodologies such as Scrum and SAFe. SAFe Product Owner/Product Manager (POPM) certification or similar Agile or product certification is desirable. Experience collaborating with cross-functional teams including clinical operations, UX/design, engineering, architecture, data, quality, regulatory, and technology stakeholders. 
• Strong communication, facilitation, presentation, and product demonstration skills.
•  Ability to work through ambiguity, make informed product decisions, and manage multiple priorities and dependencies. 
• Familiarity with DevOps, CI/CD, cloud technologies, data platforms, automation, and modern software delivery practices is a plus. 

Experience (Minimum Required): 

• 5+ years of experience as a Product Owner, Product Manager, Business Product Lead, or similar role responsible for developing and delivering digital products, preferably within life sciences or clinical research. Demonstrated experience taking product ideas from problem identification and concept development through functional design, prototyping, development, release, and continuous improvement.
•  Experience working directly with users and business stakeholders to understand workflows and translate needs into intuitive technology solutions. Hands-on experience creating prototypes, mock-ups, proofs of concept, or other demonstrations of proposed product functionality is strongly preferred. 
• Experience delivering complex technology solutions in a regulated environment, including GxP and/or 21 CFR Part 11 environments. 
• Hands-on experience working with Agile product teams and participating in Program Increment Planning or similar planning practices. 
• Experience with clinical trial technologies such as CTMS, eTMF, EDC, monitoring solutions, or related clinical operations platforms. 
• Strong analytical and problem-solving skills with the ability to move between business problems, user experience, functional design, and technical delivery. 

Learn more about our EEO & Accommodations request here.