Senior Clinical Trial Manager

ŌURA

Senior Clinical Trial Manager overseeing regulated clinical trials at Ōura. Driving study execution to support FDA-cleared features and product capabilities.

Posted 7/9/2026full-timeRemote • California, Massachusetts • 🇺🇸 United StatesSenior💰 $143,650 - $169,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading end-to-end clinical trials, including planning, execution, and oversight, while ensuring compliance with FDA regulations and ICH-GCP standards. Proven ability to manage CROs and vendors effectively, mentor clinical trial teams, and drive strategic decision-making in a fast-paced environment.

Highest-signal resume keywords

Clinical Trial LeadershipRegulatory Compliance (FDA, ICH-GCP, ISO 14155)CRO and Vendor ManagementClinical Operations Systems (EDC, eCOA/ePRO, CTMS)Strategic Decision-Making

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Hard Skills

Clinical Trial ManagementFeasibility AnalysisData Quality MonitoringStudy DocumentationScenario PlanningPerformance ManagementEvidence GenerationRisk IdentificationBudget DevelopmentStudy Oversight

Soft Skills

Stakeholder ManagementCommunicationMentoringCollaborationAdaptability

Tools & Technologies

EDCECOA/ePROETMFCTMSDashboardsTrackers

Industry Keywords

Regulated Clinical TrialsSoftware as a Medical Device (SaMD)Clinical Research StrategyMedical Device RegulationsClinical Quality Assurance

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.
Contribute to clinical research strategy, ensuring alignment with intended indications, evidence generation plans, and applicable FDA and international regulatory requirements.
Lead sponsor-side CRO and vendor management across the full study lifecycle, including vendor selection, onboarding, governance, issue escalation, and closeout.
Provide guidance and lead escalations on complex clinical quality, CRO, or vendor performance issues, advising senior leadership to support sound, well-informed decision-making.
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.
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.
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.
Drive study-level strategic decision-making by proactively identifying emerging risks and challenges, developing scenario plans and contingency options, and proposing innovative solutions to keep trials on track when circumstances change.
Help strengthen and maintain 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 just within a single study, and proactively recommend process changes to leadership.
Mentor and provide operational guidance to Clinical Trial Managers and Clinical Research Coordinators, supporting colleagues as they navigate escalations, ambiguity, and clinical research feedback.

Requirements

What you’ll need

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.

Benefits

Comp & perks

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
20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off
Paid sick leave and parental leave