Product Owner - Clinical Trials ( 100 % Remote )
Iris Software Inc.
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Job summary
Pharmaceutical Co. is seeking a Product Manager/Product Owner with Clinical Trial Platform experience to define the product vision, strategy, and roadmap for technologies supporting end-to-end clinical trial execution.
The role requires deep knowledge of regulated workflows, ensuring the platform delivers measurable value to sponsors, CROs, sites, and patients. You will drive feature development across study startup, screening, randomization, scheduling, data capture, and compliance.
Qualifications
- Bachelor’s degree or higher required in life sciences, engineering, product management, or related field.
- 3–7 years of product management experience, ideally within clinical trials, healthcare technology, or regulated SaaS platforms.
- Strong understanding of clinical trial workflows (eligibility, screening, randomization, visit scheduling, data capture, protocol adherence).
- Experience translating complex workflows into clear product requirements.
- Excellent communication skills with the ability to influence cross functional teams and senior stakeholders.
Responsibilities
- Define and articulate the product vision for a unified clinical trial platform supporting decentralized, hybrid, and site based studies.
- Identify unmet needs across patient identification, trial matching, screening, site intake, randomization, scheduling, and data flows.
- Translate market trends, regulatory requirements, and customer insights into strategic product outcomes (efficiency, compliance, adoption, data quality).
- Conduct competitive analysis and monitor industry guidelines to ensure the platform remains compliant and differentiated.
- Own the product backlog, EPICs, and feature definitions with detailed acceptance criteria, user flows, and value statements.
- Develop user personas, user stories, workflows, and prototypes to support engineering and design teams.
- Partner with engineering, clinical SMEs, data teams, and QA to ensure delivery meets quality, compliance (including 21 CFR Part 11), and performance expectations.
- Support sprint planning, refinement, and release scoping.
- Act as the voice of sponsors, CROs, investigators, research coordinators, and patients.
- Conduct discovery sessions at research sites and sponsor teams to understand workflow constraints and pain points.
- Gather and synthesize customer feedback to inform prioritization and continuous improvement.
- Collaborate with commercial, operations, data services, and regulatory teams to ensure alignment across product initiatives.
Skills
Education
Job description
Our Client which is a large Pharmaceutical Co. is urgently looking to hire Product Manager/ Product Owner with Clinical Trial Platform experience.
Key Skills - Product Ownership, Clinical Trials / IRB, Agile , Pharmaceutical Domain.
The Product Owner for the Clinical Trial Platform is responsible for defining the product vision, strategy, and roadmap for technology that supports end to end clinical trial execution.
This role blends product management discipline with deep understanding of regulated clinical workflows, ensuring the platform delivers measurable value to sponsors, CROs, research sites, and patients. The PM drives feature development across study startup, patient identification, eligibility, randomization, visit scheduling, data capture, workflow orchestration, and compliance.
Define and articulate the product vision for a unified clinical trial platform supporting decentralized, hybrid, and site based studies.
Identify unmet needs across patient identification, trial matching, screening, site intake, randomization, scheduling, and data flows.
Translate market trends, regulatory requirements, and customer insights into strategic product outcomes (efficiency, compliance, adoption, data quality).
Conduct competitive analysis and monitor industry guidelines to ensure the platform remains compliant and differentiated.
Build and maintain a clear, actionable roadmap balancing long term platform evolution with short term operational needs.
Prioritize features using transparent decision frameworks that weigh user value, regulatory impact, technical feasibility, and business goals.
Communicate roadmap updates to internal and external stakeholders.
Own the product backlog, EPICs, and feature definitions with detailed acceptance criteria, user flows, and value statements.
Develop user personas, user stories, workflows, and prototypes to support engineering and design teams.
Partner with engineering, clinical SMEs, data teams, and QA to ensure delivery meets quality, compliance (including 21 CFR Part 11), and performance expectations.
Support sprint planning, refinement, and release scoping.
Act as the voice of sponsors, CROs, investigators, research coordinators, and patients.
Conduct discovery sessions at research sites and sponsor teams to understand workflow constraints and pain points.
Gather and synthesize customer feedback to inform prioritization and continuous improvement.
Collaborate with commercial, operations, data services, and regulatory teams to ensure alignment across product initiatives.
Coordinate release readiness across training, documentation, communications, and customer facing teams.
Define and track adoption, usage, and performance metrics to measure product success.
Use platform analytics to identify opportunities for optimization and new capabilities.
- Bachelor’s degree in life sciences, engineering, product management, or related field.
- 3–7 years of product management experience, ideally within clinical trials, healthcare technology, or regulated SaaS platforms.
- Strong understanding of clinical trial workflows (eligibility, screening, randomization, visit scheduling, data capture, protocol adherence).
- Experience translating complex workflows into clear product requirements.
- Demonstrated ability to manage competing priorities and deliver high-quality features in iterative development cycles.
- Excellent communication skills with ability to influence cross functional teams and senior stakeholders.
- Experience working at a sponsor, CRO, research site, or clinical technology company.
- Familiarity with regulatory frameworks (GCP, 21 CFR Part 11, GDPR, HIPAA).
- Experience with AI enabled product capabilities or advanced analytics in clinical research.
- Prior involvement in decentralized or hybrid clinical trial technologies.
- User centered design
- Clinical workflow understanding
- Technical fluency (SaaS, integrations, data flows)
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