Senior Clinical Trial Manager

About the role

The Senior Clinical Trial Manager plays a pivotal role in the Clinical Research Operations team, overseeing the execution of regulated clinical trials that support Oura's Software as a Medical Device (SaMD) roadmap. This role is critical in generating the clinical evidence necessary to support FDA-cleared features and enabling regulatory submissions.

Responsibilities

• 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.
• Contribute to clinical research strategy, ensuring alignment with intended indications, evidence generation plans, and applicable FDA and international regulatory requirements.
• Lead sponsor-side CRO and vendor management across the full study lifecycle, including vendor selection, onboarding, governance, issue escalation, and closeout.
• Provide guidance and lead escalations on complex clinical quality, CRO, or vendor performance issues, advising senior leadership to support sound, well-informed decision-making.
• Partner closely across Science collaborators, Product, Engineering, Regulatory, Quality, 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.
• Identify systemic risks or gaps across the clinical portfolio, not just within a single study, and proactively recommend process changes to leadership.
• Mentor and provide operational guidance to Clinical Trial Managers and Clinical Research Coordinators, supporting colleagues as they navigate escalations, ambiguity, and clinical research feedback.

Requirements

• 5+ years of full-time experience leading clinical trials end to end in an industry setting (including experience as the Trial Lead), with direct ownership of clinical trials from planning and study start-up through 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 regulator-defensible 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.
• Demonstrated experience advising on or shaping clinical research strategy, including alignment of study design, endpoints, and operational approach with intended claims, market indication, and regulatory pathway.
• Experience mentoring or providing guidance to other clinical trial managers or clinical research coordinators.
• 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.

Preferred qualifications

• 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

Pay

Region 1: $143,650 - $169,000
Region 2: $130,500 - $153,000
Region 3: $117,300 - $138,000

Schedule

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