Senior Clinical Trial Manager

Our mission at Oura is to empower every person to own their inner potential. Our award‑winning products help our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We’ve helped millions of people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles. Empowering the world starts with living our values and empowering our team. As a quickly growing company focused on helping people live healthier and happier lives, we ensure that our team members have what they need to do their best work — both in and out of the office. 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 Senior Clinical Trial Manager to join our Clinical Research Operations team, leading the end‑to‑end execution of regulated clinical trials that support Oura’s Software as a Medical Device (SaMD) roadmap, while providing overall leadership and guidance across studies. 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. What you will do: 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. This is a remote US role with a slight preference for candidates based in San Francisco or Boston. Requirements We would love to consider you for this role if you have: 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 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. At Oura, we care about you and your well‑being. Everyone here at Oura has a ring of their own and we are continually looking to improve employee health. What we offer: Competitive salary and equity packages Health, dental, vision insurance, and mental health resources An Oura Ring of your own plus employee discounts for friends & family 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off Paid sick leave and parental leave Oura takes a market‑based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates’ pay will be determined based on job‑related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future. Region 1 $143,650 - $169,000 Region 2 $130,050 - $153,000 Region 3 $117,300 - $138,000 A recruiter can determine your Region based on your US location. We are not considering candidates residing in the following states: Alaska (AK), Delaware (DE), Iowa (IA), Mississippi (MS), Nebraska (NE), South Dakota (SD), West Virginia (WV), and Wisconsin (WI). EEO Statement Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regard to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics. We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Disclaimer: Beware of fake job offers! We’ve been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Please note: Our jobs are listed only on the ŌURA Careers page and trusted job boards. We will never ask for personal information like ID or payment for equipment upfront. Official offers are sent through Docusign after a verbal offer, not via text or email. Stay cautious and protect your personal details. #J-18808-Ljbffr