Senior Clinical Trial Manager

Posted 17 Days Ago
Be an Early Applicant
Hiring Remotely in United States
Remote
117K-169K Annually
Senior level
Artificial Intelligence • Information Technology • Machine Learning • Marketing Tech • Software • Biotech • Design
The Role
Lead end-to-end planning and execution of regulated clinical trials for SaMD, manage CROs and vendors, ensure data quality (EDC/ePRO/eTMF), align studies with regulatory strategy, strengthen QMS, identify portfolio risks, and mentor clinical operations staff to generate regulator-defensible evidence for FDA submissions.
Summary Generated by Built In

Our mission at Oura is to empower every person to own their inner potential. Our award-winning products help our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We've helped millions of people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles.

Empowering the world starts with living our values and empowering our team. As a quickly growing company focused on helping people live healthier and happier lives, we ensure that our team members have what they need to do their best work — both in and out of the office. 

Our Research Operations team helps turn that ambition into reality by designing and executing human research studies, which power our R&D and bolster our scientific credibility.

We are looking for a Senior Clinical Trial Manager to join our Clinical Research Operations team, leading the end-to-end execution of regulated clinical trials that support Oura's Software as a Medical Device (SaMD) roadmap, while providing overall leadership and guidance across studies. This role will be central to generating the clinical evidence needed to support FDA-cleared features. Your work will directly enable regulatory submissions and unlock new product capabilities for Oura’s users.

What you will do: 

  • 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.

This is a remote US role with a slight preference for candidates based in San Francisco or Boston.

Requirements

We would love to consider you for this role if you have:

  • 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.

Preferred qualifications

  • 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

We have offices in San Francisco, San Diego and Los Angeles for those who prefer hybrid or office settings. Oura employees in other major cities (like Boston and New York) occasionally gather informally at local co-working locations.

Benefits 

At Oura, we care about you and your well-being. Everyone here at Oura has a ring of their own and we are continually looking to improve employee health.

What we offer:

  • 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

Oura takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates' pay will be determined based on job-related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future.

  • Region 1 $143,650 - $169,000
  • Region 2 $130,050 - $153,000
  • Region 3 $$117,300 - $138,000

A recruiter can determine your Region based on your US location.

We are not considering candidates residing in the following states: Alaska (AK), Delaware (DE), Iowa (IA), Mississippi (MS), Nebraska (NE), South Dakota (SD), West Virginia (WV), and Wisconsin (WI).

Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regard to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics.

We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Disclaimer: Beware of fake job offers!
We’ve been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Please note:

  • Our jobs are listed only on the ŌURA Careers page and trusted job boards.
  • We will never ask for personal information like ID or payment for equipment upfront.
  • Official offers are sent through Docusign after a verbal offer, not via text or email.

Stay cautious and protect your personal details.

To all recruitment agencies: Oura does not accept agency resumes. Please do not forward resumes to our jobs alias, Oura employees, or any other organization's location. Oura is not responsible for any fees related to unsolicited resumes.

Skills Required

  • 5+ years of full-time experience leading clinical trials end to end in an industry setting, including experience as the Trial Lead.
  • Strong experience in regulated medical device and/or SaMD trials with understanding of ICH-GCP, ISO 14155, and FDA device regulations.
  • Expertise with SaMD clinical trials and working 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, aligning design, endpoints, and operational approach with intended claims 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; ability to communicate tradeoffs, navigate ambiguity, and move cross-functional work forward.
  • Exceptional documentation skills, including decision-making frameworks, scenario planning, and regulatory-grade study documentation.
  • Flexibility with scheduling, including occasional travel and regular global team calls outside normal business hours.
  • Collaborative, low-ego working approach with strong ownership, willingness to learn, and commitment to a supportive team culture.
  • Experience managing decentralized human subject research studies.
  • Experience supporting regulatory submissions with the FDA or regulators outside the US (e.g., EU MDR).
  • Experience supporting regulatory audits for study compliance.

Ōura Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Ōura and has not been reviewed or approved by Ōura.

  • Fair & Transparent Compensation Compensation is considered competitive for a midsize, high‑growth company, supported by posted role‑ and location‑based pay bands that signal structured ranges. A public equal‑pay pledge reinforces attention to fairness.
  • Equity Value & Accessibility Equity is a meaningful part of total compensation at a growing company, contributing to perceived upside over time. This ownership component complements base pay in the total rewards mix.
  • Leave & Time Off Breadth The package includes substantial PTO, paid holidays, and dedicated wellness days that together exceed a basic time‑off offering. This breadth of time away supports recovery and balance.

Ōura Insights

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The Company
HQ: Oulu
850 Employees
Year Founded: 2013

What We Do

Oura is an award-winning and fast-growing startup that helps people track all stages of sleep and activity using the Oura Ring and connected app. By providing daily feedback and practical steps to inspire healthy lifestyles, we've helped hundreds of thousands of people improve their sleep, understand their bodies, and transform their health. We’re on a mission to empower every person to own their inner potential, and we’re seeking talented individuals to join us on our journey. JOIN THE OURA TEAM Oura is full of skilled experts and we’re known to share a good laugh every now and then. We always strive to learn more and dig deeper into our research and analytics, to stay engaged and creative in everything we do. We respect our partners, privacy and the scientific method. We are a multi-disciplinary team of over 100 experts in hardware engineering, software development, machine learning, bioscience, sleep, industrial and UX design, production, marketing and customer experience. Oura Health Ltd.’s HQ and major manufacturing facilities are located in Oulu, Finland. Other locations include Helsinki and San Francisco.

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