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Role Overview:
- Own end-to-end planning and execution of regulated clinical trials supporting Oura's SaMD roadmap.
- Lead sponsor-side CRO and vendor management across the full study lifecycle.
- Partner across Science, Product, Engineering, Regulatory, Quality, and Legal to align study execution with goals.
Key Responsibilities:
- Develop clinical investigation plans, contracts, budgets, timelines, and trial oversight.
- Ensure high-quality evidence generation via EDC, eCRFs, data review, and database lock.
- Drive study-level strategic decision-making by identifying risks and proposing solutions.
Qualifications:
- 3+ years leading clinical trials end to end in industry.
- Strong experience in regulated medical device/SaMD trials with ICH-GCP and FDA regulations.
- Proven CRO, vendor, and site management experience with hands-on clinical operations systems.
Oura
Oura empowers people to own their inner potential with award-winning products that provide insights into readiness, activity, and sleep quality. As a quickly growing company, we focus on helping people live healthier and happier lives, ensuring our team members have what they need to do their best work.