Note: The job is a remote job and is open to candidates in USA. OneStudyTeam, a Reify Health company, specializes in enhancing clinical trials through their cloud-based platform, StudyTeam. The Product Operations Lead will be responsible for executing product requirements, managing backlogs, validating features, and ensuring compliance in a regulated healthcare environment.
Responsibilities
- Deliver the Core Artifacts: Write clear business requirements, user stories, acceptance criteria, and functional specifications
- Maintain the Backlog: Prioritize, refine, and sequence the product backlog in close coordination with product, engineering, and business stakeholders
- Roadmap Slicing: Convert high-level roadmap items into smaller, practical delivery milestones and value slices
- Functional Validation: Validate newly developed features against initial requirements and expected system behavior before release
- Defect Triage: Review QA findings to determine whether issues are system defects, requirement gaps, or usability concerns
- UAT Support: Coordinate User Acceptance Testing (UAT) and consolidate feedback from business users and clients
- Schedule Ownership: Track product delivery schedules, release readiness, risks, blockers, and open functional decisions
- Stakeholder Updates: Provide regular delivery updates and support internal or executive presentations regarding release progress and tradeoffs
- Rollout Preparation: Support Go-To-Market (GTM) efforts by preparing customer facing release notes, documentation, and feature limitation communications
- Cross-Team Communication: Bridge communication between product, engineering, QA, customer success, operations, and leadership
- GxP Alignment: Ensure requirements and final release packages adhere to GxP compliance standards, validation protocols, and audit-readiness in a regulated healthcare software environment. Partnering with Compliance and Quality teams to drive automation to make this process as efficient as possible
- Performance Monitoring: Track and summarize adoption metrics, usage statistics, and product KPIs to inform future feature prioritization
Skills
- 2–4 years of experience working in Agile software development environments as a Product Owner, Business Analyst, Data Analytics, or similar role
- Strong understanding of SQL, APIs, JSON
- Using LLMs in support of day to day activities
- Experience in SaaS, enterprise software, or healthcare workflow environments
- Direct familiarity with GxP compliance guidelines and validated software environments
- Proven capability to write structured user stories, non-functional requirements (e.g., browser/resolution support), validation rules, and acceptance criteria
- Strong organizational skills with a proven track record of managing a backlog, resolving day-to-day development blockers, and validating technical deliverables
Company Overview
OneStudyTeam is a cloud-based software company that work to ensure therapeutic development moves at the speed of science. It is a sub-organization of Reify Health. It was founded in 2012, and is headquartered in Boston, Massachusetts, USA, with a workforce of 201-500 employees. Its website is https://www.onestudyteam.com.