Senior Clinical Trial Manager

Oura Oura · Consumer · United States · Remote · Science

This role manages end-to-end regulated clinical trials for Oura's Software as a Medical Device (SaMD) roadmap, focusing on generating clinical evidence for FDA-cleared features. It involves planning, execution, CRO/vendor management, and cross-functional collaboration to ensure regulatory compliance and support new product capabilities.

What you'd actually do

  1. 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.
  2. Contribute to clinical research strategy, ensuring alignment with intended indications, evidence generation plans, and applicable FDA and international regulatory requirements.
  3. Lead sponsor-side CRO and vendor management across the full study lifecycle, including vendor selection, onboarding, governance, issue escalation, and closeout.
  4. Provide guidance and lead escalations on complex clinical quality, CRO, or vendor performance issues, advising senior leadership to support sound, well-informed decision-making.
  5. 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.

Skills

Required

  • 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.

Nice to have

  • 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 conduct

What the JD emphasized

  • regulated clinical trials
  • Software as a Medical Device (SaMD)
  • FDA
  • ICH-GCP
  • ISO 14155
  • FDA device regulations
  • regulator-defensible study conduct