healthcare
Posted 2 weeks agoClinical Trial Manager
at oura
United StatesHybrid
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.
- Lead sponsor-side CRO and vendor management across the full study lifecycle, including vendor selection, onboarding, governance, issue escalation, and closeout.
- 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.
Requirements
- 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.
- 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.
- 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 [REQUIREMENTS] 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
Experience
- 3+ years of full-time
Benefits
- 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
- 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.
- Region 1 $93,500 - $110,000
- Region 2 $85,000 - 1$100,000
- Region 3 $79,900 - $94,000
- 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
Additional details
- Our mission at Oura is to empower every person to own their inner potential.
- 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 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.
- 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.