The Clinical Operations Manager serves as a dedicated functional expert within a cross-functional (XFN) team, contributing specific subject matter expertise (SME) to ensure operational execution of clinical studies. This role focuses directly on driving core operational milestones, clinical study documentation, and compliance frameworks from study design through study closeout. The Clinical Operations Manager owns critical study documentation, risk management strategy, site selection and qualification, monitoring oversight, and safety/deviation workflows from study start-up through to study close-out, collaborating within cross-functional teams to drive successful end-to-end study execution.

• Author and establish critical study documentation, including Clinical Protocols, Informed Consent Forms (ICFs), and participant-facing materials.

• Implement study operational plans, including the Integrated Quality Risk Management Plan (IQRMP) and Study Monitoring Plan, alongside clinical SOPs.

• Serve as the primary contact for clinical sites, managing site operations, protocol deviations, adverse event evaluations, and IRB reporting; and, oversees electronic Trial Master Files (eTMFs) to ensure full GCP compliance, regulatory adherence, and continuous audit readiness.

• Support the research agenda across teams, including managing research timelines across the business from inception to publication.

• Work across the Research/EvGen/Clinical Quality Teams to provide project management support for projects that further business strategy for evidentiary claim development.

Minimum Qualifications

• Bachelor's degree in a life sciences, healthcare, or technical field, or equivalent practical experience.

• 4+ years of direct experience in clinical operations, clinical trial management, or a related operational role within healthcare or biotechnology.

• Direct experience drafting clinical study documentation (protocols, ICFs) and managing eTMF systems.

• Strong subject matter expertise (SME) working inside cross-functional (XFN) project or product teams.

Preferred Qualifications

• Deep familiarity with GCP compliance, regulatory submission considerations, and clinical SOP development.

• Excellent communication skills with the ability to provide clear clinical operational guidance to cross-functional stakeholders.

• Strong organizational skills that ensure development of evidentiary claims across the organization consistent with the commercial needs.

• Project management certification; experience with JIRA.

Qualified applicants must not require employer sponsored work authorization now or in the future for employment in the United States.

The US base salary range for this full-time position is $119,000 - $179,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.