Clinical Trial Manager

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Take charge of the comprehensive planning and execution of regulated clinical trials from initiation to closure, encompassing feasibility assessments, the creation of clinical investigation plans, contracts, budgets, timelines, trial oversight, data quality monitoring, and overall study leadership and decision-making.

• Oversee sponsor-side CRO and vendor management throughout the entire study lifecycle, including vendor selection, onboarding, governance, issue escalation, and closeout.

• Collaborate closely with Science collaborators, Product, Engineering, Regulatory, Quality, Program, Clinical Data Management, Legal, and external partners to ensure alignment of study execution with product, clinical, and regulatory objectives.

• Convert study requirements into operational plans, which include protocol-related planning, study-specific documentation, training, reporting needs, and essential study management tools like dashboards, trackers, and decision logs.

• Partner with CROs and data management teams to guarantee the generation of high-quality and auditable evidence across eCRFs, EDC builds, data review workflows, data cleansing, and database lock.

• Facilitate strategic decision-making at the study level by proactively identifying emerging risks and challenges, formulating scenario plans and contingency options, and suggesting innovative solutions to keep trials on track as circumstances evolve.

• Contribute to the enhancement and maintenance of Oura’s Quality Management System by assisting in the development of SOPs, templates, work instructions, and repeatable study playbooks.

⛳️ Requirements

• A minimum of 3 years of full-time experience managing clinical trials from start to finish in an industry context, with direct responsibility for planning, study initiation, execution, oversight, and closure.

• Extensive experience in regulated medical device and/or SaMD trials, with a strong grasp of ICH-GCP, ISO 14155, relevant FDA device regulations, and audit-ready study conduct.

• Proficiency in Software as a Medical Device (SaMD) clinical trials, with a demonstrated capability to manage multiple data streams such as EEG, CGM, ePRO, and consumer wearables.

• Solid experience in CRO, vendor, and/or site management, including accountability, escalation, and performance management.

• Practical experience with essential clinical operations systems and processes like EDC, eCOA/ePRO, eTMF, CTMS, and standard clinical study documentation.

• Strong project and stakeholder management skills, with the ability to clearly communicate trade-offs, navigate ambiguity, and advance complex cross-functional projects in a fast-paced environment.

• Outstanding documentation skills, including decision-making frameworks, scenario planning, and study documentation capable of withstanding regulatory scrutiny.

• Willingness to accommodate flexible scheduling, which may include occasional travel and regular global team calls outside of standard business hours.

• A highly collaborative and low-ego approach to work, combined with a strong sense of ownership, a readiness to learn and adapt, and a genuine commitment to promoting 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