Clinical Trial Manager

ŌURA

Clinical Trial Manager overseeing clinical trials for Oura’s Software as a Medical Device. Ensuring regulatory compliance and collaboration with cross-functional teams.

Posted 7/9/2026full-timeRemote • California, Massachusetts • 🇺🇸 United StatesMid-LevelSenior💰 $93,500 - $110,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in leading regulated clinical trials, including planning, execution, and oversight, while ensuring compliance with ICH-GCP and FDA regulations. Proficient in managing CROs and vendors, with strong project management and documentation skills to support high-quality evidence generation.

Highest-signal resume keywords

Clinical Trial ManagementRegulated Medical Device TrialsCRO and Vendor ManagementEDC and ePRO SystemsStakeholder Management

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Trial PlanningStudy Start-UpData Quality MonitoringRegulatory ComplianceScenario PlanningDocumentation SkillsData Review WorkflowsDatabase LockQuality Management SystemSOP Development

Soft Skills

CollaborationCommunicationAdaptabilityOwnershipProblem-Solving

Tools & Technologies

EDCECOAEPROETMFCTMS

Industry Keywords

ICH-GCPISO 14155FDA Device RegulationsSoftware as a Medical Device (SaMD)Clinical Investigation Plans

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

Requirements

What you’ll need

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.
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