Clinical Trial Manager

Oura Oura · Consumer · United States · Remote · Science

Oura is seeking a Clinical Trial Manager to lead end-to-end execution of regulated clinical trials for their Software as a Medical Device (SaMD) roadmap, crucial for supporting FDA-cleared features and regulatory submissions. The role involves study planning, CRO/vendor management, cross-functional collaboration, data quality monitoring, and ensuring audit-ready study conduct.

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. Lead sponsor-side CRO and vendor management across the full study lifecycle, including vendor selection, onboarding, governance, issue escalation, and closeout.
  3. 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.
  4. 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.
  5. 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.

Skills

Required

  • 3+ years of full-time 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.
  • Exceptional documentation skills, including decision-making frameworks, scenario planning, and study documentation that can stand up to regulatory scrutiny.

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 compliance

What the JD emphasized

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