Clinical Trial Manager

Our Research Operations team helps turn that ambition into reality by designing and executing human research studies, which power our R&D and bolster our scientific credibility.

We are looking for a Clinical Trial Manager to join our Clinical Research Operations team and lead the end-to-end execution of regulated clinical trials supporting Oura’s Software as a Medical Device (SaMD) roadmap. This role will be central to generating the clinical evidence needed to support FDA-cleared features. Your work will directly enable regulatory submissions and unlock new product capabilities for Oura’s users.

• →Own end-to-end planning and execution of regulated clinical trials from study start-up through close-out, including feasibility analysis, development of clinical investigation plans, contracts and budgets, timelines, trial oversight, data quality monitoring, and overall study leadership and decision-making.
• →Lead sponsor-side CRO and vendor management across the full study lifecycle, including vendor selection, onboarding, governance, issue escalation, and closeout.
• →Partner closely across Science collaborators, Product, Engineering, Regulatory, Quality, Program, Clinical Data Management, Legal, and external partners to align study execution with product, clinical, and regulatory goals.
• →Translate study requirements into operational plans, including protocol-related planning, study-specific documentation, training, reporting needs, and core study management tools such as dashboards, trackers, and decision logs.
• →Work closely with CROs and data management partners to ensure high-quality and auditable evidence generation across eCRFs, EDC build, data review workflows, data cleaning, and database lock.
• →Drive study-level strategic decision-making by proactively identifying emerging risks and challenges, developing scenario plans and contingency options, and proposing innovative solutions to keep trials on track when circumstances change.
• →Help strengthen and maintain Oura’s Quality Management System by contributing to SOPs, templates, work instructions, and repeatable study playbooks.

This is a remote US role with a slight preference for candidates based in San Francisco or Boston.

• Experience managing decentralized human subject research studies
• Experience supporting regulatory submissions with the FDA in the US or with regulators outside the US (e.g. EU MDR)
• Experience supporting regulatory audits for study compliance

We have offices in San Francisco, San Diego and Los Angeles for those who prefer hybrid or office settings. Oura employees in other major cities (like Boston and New York) occasionally gather informally at local co-working locations.

• 3+ years of full-time experience leading clinical trials end to end in an industry setting, with direct ownership of planning, study start-up, execution, monitoring oversight, and close-out.
• Strong experience in regulated medical device and/or SaMD trials, with a solid understanding of ICH-GCP, ISO 14155, applicable FDA device regulations, and audit-ready study conduct.
• Expertise with Software as a Medical Device (SaMD) clinical trials, with a proven ability to work with multiple data streams such as EEG, CGM, ePRO, and consumer wearables.
• Proven CRO, vendor, and/or site management experience, including accountability, escalation, and performance management.
• Hands-on experience with core clinical operations systems and processes such as EDC, eCOA/ePRO, eTMF, CTMS, and standard clinical study documentation.
• Strong project and stakeholder management skills, with the ability to communicate tradeoffs clearly, navigate ambiguity, and move complex cross-functional work forward in a fast-paced environment.
• Exceptional documentation skills, including decision-making frameworks, scenario planning, and study documentation that can stand up to regulatory scrutiny.
• Flexibility with scheduling, including occasional travel and regular global team calls outside normal business hours.
• A highly collaborative and low-ego working approach, paired with a strong sense of ownership, a willingness to learn and adapt, and a genuine commitment to fostering a supportive and uplifting team culture.