Product Owner with Clinical Trial domain

Iris Software is recruiting for an unnamed client seeking a Product Owner for a clinical trial platform. The role defines product vision and roadmaps, leads feature development, and supports end-to-end clinical trial workflows while ensuring compliance and measurable product value.

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Analytics

Big Data

Information Technology

Software

Hiring Manager

Ankit Grover

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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

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

Preferred

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

Benefits

Fully remote role

Glassdoor

4.1

Enterprise software engineering and application development services.

Edison, New Jersey, USA

https://www.irissoftware.com

Late Stage

Leadership Team

Anil Apte

Managing Director

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Qualifications

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

Product strategy & prioritization

Clinical workflow understanding

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

3–7 years of product management experience, ideally within clinical trials, healthcare technology, or regulated SaaS platforms.

Required skills

Product Management, Clinical Trial Workflows, Clinical Trial Platforms, Product Requirements, Iterative Product Development, Clinical Practice (GCP), 21 CFR Part 11, GDPR, HIPAA, AI in Clinical Research, Advanced Analytics in Clinical Research, Decentralized Clinical Trials, Cross-functional Stakeholder Influence

Experience

3-7 years