Oura

Clinical Trial Manager

Remote - United States · Full-time

Sponsorship not specified$94k-$110kDetected 12 days ago

GCPStakeholder ManagementVendor ManagementClinical TrialsClinical ResearchFDA RegulatoryMedical DevicesResearchLeadership

About the role

We've helped millions of people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles.
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.

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.
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.
An Oura Ring of your own plus employee discounts for friends & family

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

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

Everyone here at Oura has a ring of their own and we are continually looking to improve employee health.
Competitive salary and equity packages
Health, dental, vision insurance, and mental health resources
20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off
Paid sick leave and parental leave
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.
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.

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.
Flexibility with scheduling, including occasional travel and regular global team calls outside normal business hours.
At Oura, we care about you and your well-being.
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).

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

This listing is sourced directly from Oura's careers page and normalized into a canonical job model.