Oura is looking to scale its clinical research operations function to enable regulatory submissions and unlock new product capabilities for Oura's users.
Requirements
- 5+ years of full-time experience running clinical trials end-to-end, including at least 2 years supervising staff and managing CRO/vendor relationships
- A track record of managing research studies for regulatory submissions in an industry setting, including study startup, requirement identification, resource allocation, study execution/maintenance, compliance, risk management, and source documentation
- Expertise with digital health or medical device trials (SaMD), with a proven ability to work with multiple data streams (e.g. EEG, CGM, ePRO, consumer wearables), resolve quality issues at the source, and fulfill regulatory requirements (FDA, GCP, ICH)
- Exceptional documentation and process-building skills, including authoring SOPs, templates, and study documentation that stand up to regulatory scrutiny, and a growth-oriented mindset
Responsibilities
- Own and oversee all aspects of clinical trials—including feasibility analysis, budgets, contracts, development of clinical investigation plans and protocols, regulatory submissions, logistics, troubleshooting, and data quality monitoring
- Manage and grow a clinical operations squad—scaling our in-house research study capabilities
- Expand our network of research partners—identifying, vetting, and building relationships with institutional partners and CROs to complement our internal capabilities
- Collaborate with science, engineering, regulatory, clinical, product, and legal teams—developing efficient processes to enable regulatory submissions
- Build internal processes—proposing and implementing new tools, processes, and templates that allow the team to move faster while preserving scientific rigor
Other
- Experience working on large cross-functional teams in a fast-paced setting, bringing structure to ambiguity
- Flexibility with scheduling: comfortable with occasional site visits and global team calls outside normal business hours
- 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
