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Clinical Product Owner

2 semanas atrás

São Paulo, São Paulo, Brasil beBeeClinicalProductOwner Tempo inteiro US$120.000 - US$150.000
Key Role Description

Fortrea is seeking a highly skilled and proactive Product Owner to support the development and delivery of clinical trial technology solutions. As the key liaison between business stakeholders and Agile development teams, you will shape the product vision and prioritize features that maximize business value, enhance operational efficiency, and ensure regulatory compliance across clinical trials.

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  • Primary 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 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, 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.
Key Qualifications

The ideal candidate will possess the following 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 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.

This role offers a unique opportunity to join a dynamic team and make a meaningful impact on the development of clinical trial technology solutions.