Senior Clinical Trial Manager

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🏄 California, Massachusetts – Remote

🏄 California – Remote 🍂 Massachusetts – Remote

💵 $143.7k - $169k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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ŌURA

WebsiteLinkedInAll Job Openings

201 - 500 employees

🧘 Wellness

Wellness • Wearables • Health

ŌURA is a company that produces smart rings designed to provide in-depth health metrics and insights. The Oura Ring tracks a variety of health-related data such as sleep patterns, heart rate, activity levels, and stress. It aims to help users live healthier and more productive lives through accurate biometrics tracked via a comfortable ring worn all day and night. With features that benefit women's health, heart health, and overall wellness, ŌURA rings are marketed as both technologically advanced and user-friendly devices for personal health monitoring.

📋 Description

• 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

• 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

• 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