Product Owner with Clinical Trial domain

Iris Software Inc.; United States; Remote; USD 120,000 - 170,000; Full time

Job summary

Iris Software seeks a Product Owner for its Clinical Trial Platform on a fully remote, long-term contract. You will define the vision, strategy, and roadmap for end-to-end trial execution, collaborating with engineering, clinical SMEs, data teams, and QA to ensure quality and regulatory compliance.

Experience in regulated SaaS and clinical workflows, with strong stakeholder influence and prioritization skills, is essential for driving adoption and measurable platform value.

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).
• 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.

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.

Skills

Product Owner

Pharma/Clinical Trials

Roadmap & backlog

Stakeholder mgmt

Education

Bachelor’s degree

Job description

We have a job opportunity with our direct Client for Product Owner. It’s a long-term contract role // Fully Remote role.

Title : Product Owner

Work Schedule: Fully Remote role.

Required Skills : Product Owner with Pharma or Clinical Trial Platform

Role Overview

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 owner 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.

Key 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.

Roadmap Ownership

• 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.

Requirements & Delivery Leadership

• 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.

Product Launch, Adoption & Performance

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.

Required 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.

Preferred Qualifications

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.

Clinical workflow understanding

Thanks and Regards,

Ankit Grover

Sr. Executive - TA

Iris Software

200 Metroplex Drive, Suite #300, Edison, NJ 08817