Production Operations Lead

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OneStudyTeam

WebsiteLinkedInAll Job Openings

201 - 500 employees

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare Insurance • Biotechnology • Pharmaceuticals

OneStudyTeam is a company that provides the StudyTeam platform, a cloud-based solution designed to facilitate the clinical trial process for research sites and sponsors. The platform enhances patient enrollment management by streamlining site workflows and offering real-time insights into recruitment and enrollment data. Used globally by over 10,000 research sites and trusted by leading biopharmaceutical sponsors, OneStudyTeam aims to improve the efficiency of clinical trials and reduce the burden on research sites.

📋 Description

• 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

• 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

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