Production Operations Lead

OneStudyTeam

Production Operations Lead at OneStudyTeam, enhancing clinical trials through operational execution and feature validation. Collaborate cross-functionally to ensure successful product delivery and compliance standards.

Posted 6/11/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $100,000 - $125,000 per yearWebsite

Tech Stack

Tools & technologies

GoSQL

About the role

Key responsibilities & impact

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.
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.

Requirements

What you’ll need

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.
LLMs are a part of your DNA, using them in support of their day to day activities is paramount.
Experience in SaaS, enterprise software, or healthcare workflow environments.
The ideal candidate has direct familiarity with GxP compliance guidelines and validated software environments is highly preferred.
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.

Benefits

Comp & perks

We value diversity and believe the unique contributions each of us brings drives our success.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

SQLAPIsJSONuser storiesacceptance criteriafunctional specificationsbacklog managementvalidation rulesGxP complianceperformance monitoring

Soft Skills

organizational skillsstakeholder communicationproblem-solvingcollaborationpresentation skillsprioritizationattention to detailadaptabilitytime managementcritical thinking