Product Owner – Clinical Systems

Job Overview:

Fortrea is seeking an experienced and proactive Product Owner – Clinical Systems (CTMS, eTMF, SSU) to support the development and delivery of clinical trial technology solutions. As the key liaison between business stakeholders and Agile development teams, you will be responsible for shaping the product vision and prioritizing features that maximize business value, support regulatory compliance, and enhance operational efficiency across clinical trials.

This role focuses on Fortrea's Veeva and Siebel Clinical Trial Management System (CTMS) Veeva electronic Trial Master File (eTMF) and Veeva SSU, playing a critical role in ensuring these platforms meet the evolving needs of Clinical Development and Operations

Key Responsibilities:

• Own the product backlog for CTMS, SSU and eTMF systems, ensuring it is prioritized, refined, and aligned with business objectives and regulatory requirements.
• Gather input from stakeholders including clinical operations, regulatory affairs, quality assurance, and IT to define and document user stories, acceptance criteria, and product features.
• Translate complex clinical business requirements into scalable, compliant software solutions.
• Ensure all backlog items meet the Definition of Ready (DoR) and are clearly defined for development teams.
• Lead and participate in Program Increment (PI) Planning and Agile ceremonies to communicate priorities, dependencies, and risks.
• Collaborate with Product Management and Release Train Engineers to define the product roadmap and ensure alignment with clinical and organizational strategy.
• Act as a subject matter expert in CTMS, SSU and eTMF capabilities, guiding development teams with business context and user expectations.
• Serve as the voice of the customer, validating that solutions meet business goals, compliance standards (e.g., GxP, 21 CFR Part 11), and user needs.
• Monitor industry trends and regulatory changes to ensure Fortrea's CTMS, SSU and eTMF platforms remain cutting-edge and compliant.
• Communicate regularly with stakeholders on progress, risks, dependencies, and planned releases.

Qualifications:

• Education:
  Bachelor's degree in Life Sciences, Computer Science, or a related field. Advanced degree preferred.
• Certifications:
  SAFe Product Owner/Product Manager (POPM) certification or equivalent Agile certification strongly preferred.
• Technical & Domain Expertise:
  • Deep understanding of clinical trial processes and documentation lifecycle.
  • Experience managing CTMS (e.g., Veeva CTMS, Oracle Siebel CTMS) and eTMF, SSU systems (e.g., Veeva Vault eTMF and SSU).
  • Familiarity with clinical data standards, TMF reference models, and audit-readiness best practices.
  • Understanding of system validation practices and compliance requirements in a regulated (GxP) environment.
• Skills:
  • Proven ability to create and manage Agile artifacts including user stories, backlogs, and roadmaps.
  • Strong collaboration, communication, and facilitation skills to engage stakeholders across functions.
  • Experience working in a Scaled Agile Framework (SAFe) environment.
  • Ability to balance multiple priorities and deliver value in a fast-paced, evolving environment.

Experience:

• Minimum 5+ years of experience as a Product Owner or Business Analyst, preferably within clinical technology in the life sciences industry.
• Demonstrated experience leading the development and implementation of CTMS, SSU and/or eTMF solutions.
• Track record of successful product delivery in a regulated, Agile environment.

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