Product Owner - Clinical Systems

Devspace; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Devspace is seeking an experienced Product Owner for Clinical Systems to partner with Clinical Operations, stakeholders, and technology teams in delivering solutions for clinical trial processes.

The ideal candidate blends clinical trial domain knowledge with product ownership skills, including backlog management, user story development, and acceptance criteria, while ensuring regulatory compliance and cross-functional collaboration.

Qualifications

• Experience leading product teams in clinical or life sciences environments.
• Knowledge of regulated/GxP systems and 21 CFR Part 11 is preferred.
• Proven ability to elicit requirements, define processes, write user stories and manage backlogs.

Responsibilities

• Serve as the Product Owner for technology solutions supporting clinical trial operations and related processes.
• Translate business needs into defined features, user stories, acceptance criteria, and workflows.
• Own and prioritise the product backlog based on value, risk and stakeholder input.
• Facilitate requirements discovery and backlog grooming with business and tech teams.
• Collaborate with engineering, QA, validation, and business groups throughout development life cycle.
• Ensure solutions align with clinical processes, data requirements, and regulatory standards.
• Support UAT, release readiness, and adoption of new capabilities.
• Provide clinical systems expertise to explain business context to developers.

Skills

Product Owner experience

Clinical trials understanding

Requirements elicitation

Backlog management

UAT & acceptance criteria

Stakeholder management

Effective communication

Tools

CTMS

EDC

eTMF

Veeva

Job description

Position: Product Owner- Clinical Systems

Engagement period: Minimum 12 months with the option to extend the term

Interview timeline: ASAP

Interview process: 1) CV review 2) Interview with our CTO 3) Interview with end client

Number of interviews: 2

Description

Our client is a leading life sciences and technology company that supplies a broad range of analytical instruments, laboratory equipment, reagents, software and services used in scientific research, healthcare, biotechnology and pharmaceutical manufacturing worldwide. Its mission is to enable customers to make the world healthier, cleaner and safer by supporting breakthroughs in areas from life-sciences research and clinical diagnostics to complex analytical challenges and drug development.

They offer a wide range of scientific software products that help laboratories manage, analyze and automate data and workflows. Their portfolio includes enterprise lab informatics platforms with Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN) and data management tools.

Product Owner - Clinical Systems

The strongest profile would combine:

Clinical Trial Domain Knowledge + Clinical Systems Experience + GxP/Validation Understanding + Strong Product Ownership Skills.

Role Summary

We are seeking an experienced Product Owner (PO) - Clinical Systems to partner with Clinical Operations, business stakeholders, and technology teams in defining and delivering technology solutions supporting clinical trial processes.

The ideal candidate will combine strong clinical trial and clinical systems domain knowledge with core Product Owner capabilities, including requirements elicitation, process and workflow definition, backlog management, user story development, acceptance criteria, and prioritization.

Key Responsibilities

• Serve as the Product Owner for technology solutions supporting clinical trial operations and associated business processes.
• Partner with Clinical Operations and other stakeholders to understand business needs, pain points, workflows, and desired outcomes.
• Translate business requirements into well-defined features, user stories, acceptance criteria, and process/workflow definitions.
• Own and prioritize the product backlog based on business value, dependencies, risks, and stakeholder needs.
• Facilitate requirements discovery, refinement sessions, solution discussions, and backlog grooming with business and technology teams.
• Work closely with engineering, architecture, QA, validation, and business teams throughout the product development lifecycle.
• Ensure solutions align with clinical processes, data requirements, regulatory expectations, and enterprise standards.
• Support UAT, release readiness, implementation, and adoption of new capabilities.
• Provide clinical systems and process expertise to help technology teams understand the business context behind requirements.
• Coordinate across stakeholders and systems where clinical workflows span multiple platforms.

Required Skills & Experience

• Strong understanding of clinical trial operations and end-to-end clinical workflows.
• Experience with clinical technology platforms such as CTMS, EDC, eTMF, Veeva, or similar clinical systems.
• Understanding of clinical data concepts, data definitions, data flows, and integration/dependencies between clinical systems.
• Knowledge of 21 CFR Part 11, validation principles, and working with regulated/GxP systems.
• Demonstrated Product Owner or Business Analysis experience in:
  • Requirements elicitation and analysis
  • Business process and workflow definition
  • User stories and acceptance criteria
  • Product backlog management and prioritization
  • UAT and business acceptance
• Strong stakeholder management and communication skills with the ability to bridge business, clinical, and technical teams.
• Ability to translate complex clinical/business requirements into clear and actionable requirements for development teams.
• Prior experience within pharmaceutical, biotechnology, CRO, or life-sciences environments.

Preferred Skills

• Experience delivering or enhancing enterprise clinical applications.
• Experience working with validated computerized systems in a regulated environment.
• Familiarity with clinical system integrations and clinical data flows.
• Experience collaborating with vendors and SaaS clinical platform providers.
• Understanding of the clinical trial lifecycle from study startup through conduct and closeout.
• Experience working with globally distributed business and technology teams.

Profile We Are Looking For

A successful candidate should be more than a traditional technology Product Owner. The role requires someone who can understand the clinical business process, communicate effectively with Clinical Operations, and translate that knowledge into clear product requirements for technology teams.

Please note: Background and reference checks will be conducted as part of the selection process.