Senior Clinical Trial Manager

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Take charge of the complete planning and execution of regulated clinical trials from study initiation to close-out, encompassing feasibility assessments, creation of clinical investigation plans, contracts and budgets, timelines, trial oversight, data quality monitoring, and overall study leadership and decision-making.

• Contribute to the clinical research strategy, ensuring it aligns with intended indications, evidence generation plans, and relevant FDA and international regulatory requirements.

• Lead sponsor-side management of CROs and vendors throughout the entire study lifecycle, including vendor selection, onboarding, governance, issue escalation, and closeout.

• Offer guidance and lead escalations on intricate clinical quality, CRO, or vendor performance issues, advising senior leadership to facilitate well-informed decision-making.

• Collaborate closely with Science collaborators, Product, Engineering, Regulatory, Quality, Clinical Data Management, Legal, and external partners to ensure study execution aligns with product, clinical, and regulatory objectives.

• Convert study requirements into operational plans, including protocol-related planning, study-specific documentation, training, reporting necessities, and essential study management tools like dashboards, trackers, and decision logs.

• Work in close partnership with CROs and data management allies to guarantee high-quality and auditable evidence generation across eCRFs, EDC build, data review workflows, data cleaning, and database lock.

• Propel study-level strategic decision-making by proactively spotting emerging risks and challenges, developing scenario plans and contingency options, and suggesting innovative solutions to maintain trial schedules when circumstances shift.

• Assist in strengthening and maintaining Oura’s Quality Management System by contributing to SOPs, templates, work instructions, and repeatable study playbooks.

• Identify systemic risks or gaps across the clinical portfolio, not limited to a single study, and proactively advise leadership on process improvements.

• Mentor and provide operational guidance to Clinical Trial Managers and Clinical Research Coordinators, assisting colleagues in navigating escalations, ambiguity, and clinical research feedback.

⛳️ Requirements

• Over 5 years of full-time experience leading clinical trials from start to finish in an industry context (including experience as the Trial Lead), with direct accountability for clinical trials from planning and study initiation through execution, monitoring oversight, and close-out.

• Extensive experience in regulated medical device and/or SaMD trials, with a robust understanding of ICH-GCP, ISO 14155, applicable FDA device regulations, and regulator-defensible study conduct.

• Expertise in Software as a Medical Device (SaMD) clinical trials, demonstrating a proven ability to work with various data streams, including EEG, CGM, ePRO, and consumer wearables.

• Established experience in CRO, vendor, and/or site management, including accountability, escalation, and performance management.

• Proven track record in advising on or shaping clinical research strategy, ensuring alignment of study design, endpoints, and operational approach with intended claims, market indication, and regulatory pathway.

• Experience mentoring or guiding other clinical trial managers or clinical research coordinators.

• Practical 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 capabilities, with the ability to clearly communicate trade-offs, navigate ambiguity, and advance complex cross-functional projects in a fast-paced environment.

• Excellent documentation skills, encompassing decision-making frameworks, scenario planning, and study documentation that can withstand regulatory scrutiny.

• Flexibility in scheduling, including occasional travel and regular global team calls outside normal business hours.

• A highly collaborative and low-ego work style, combined with a strong sense of ownership, a willingness to learn and adapt, and a genuine commitment to nurturing a supportive and uplifting team culture.

🏝️ Benefits

• Competitive salary and equity packages

• Health, dental, vision insurance, and mental health resources

• An Oura Ring of your own along with employee discounts for friends & family

• 20 days of paid time off plus 13 paid holidays and 8 days of flexible wellness time off

• Paid sick leave and parental leave