Production Operations Lead
OneStudyTeam
Posted about 4 hours ago
At OneStudyTeam (a Reify Health company), we specialize in speeding up clinical trials and increasing the chance of new therapies being approved with the ultimate goal of improving patient outcomes. Our cloud-based platform, StudyTeam, brings research site workflows online and enables sites, sponsors, and other key stakeholders to work together more effectively. StudyTeam is trusted by the largest global biopharmaceutical companies, used in over 6,000 research sites, and is available in over 100 countries. Join us in our mission to advance clinical research and improve patient care.
One mission. One team. That’s OneStudyTeam.
The Product Operations Lead is responsible for the tactical execution, day-to-day definition, and functional validation of product requirements. This is an execution-focused role centered on turning business needs, customer feedback, and macro-level roadmap items into clear, actionable delivery slices for the engineering team.
What You’ll Be Working On
- Requirements Definition & Backlog Management
- 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.
- Feature Validation & QA Coordination
- 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.
- Release Tracking & Communication
- 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.
- Compliance & Operational Metrics
- 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.
What You’ll Bring to OneStudyTeam
- Experience: 2–4 years of experience working in Agile software development environments as a Product Owner, Business Analyst, Data Analytics, or similar role.
- Technology: Strong understanding of SQL, APIs, JSON.
- LLMs - LLMs are a part of your DNA, using them in support of their day to day activities is paramount.
- Domain Exposure: Experience in SaaS, enterprise software, or healthcare workflow environments.
- Life Sciences and GxP: The ideal candidate has direct familiarity with GxP compliance guidelines and validated software environments is highly preferred.
- Technical Writing: Proven capability to write structured user stories, non-functional requirements (e.g., browser/resolution support), validation rules, and acceptance criteria.
- Execution Focus: Strong organizational skills with a proven track record of managing a backlog, resolving day-to-day development blockers, and validating technical deliverables.
The expected salary range for this role is $100,000 - $125,000 USD per year for full time team members.
#LI-Remote
We value diversity and believe the unique contributions each of us brings drives our success. We do not discriminate on the basis of race, sex, religion, color, national origin, gender identity, age, marital status, veteran status, or disability status.
Note: OneStudyTeam is unable to sponsor work visas at this time. If you are a non-U.S. resident applicant, please note that OneStudyTeam works with a Professional Employer Organization.
As a condition of employment, you will abide by all organizational security and privacy policies.
This organization participates in E-Verify (E-Verify's Right to Work guidance can be found here).
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: OneStudyTeam may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: OneStudyTeam complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: OneStudyTeam complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. OneStudyTeam is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
