Clinical Trial Manager

Company DescriptionIt started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.Job DescriptionThe Clinical Trial Manager (CTM) will manage the day-to-day planning and execution of clinical studies to generate evidence supporting the safety, performance, and clinical utility of novel robotics, imaging, and AI-based products. This role is highly operational and execution-focused, partnering closely with clinical sites, CROs/vendors, and internal cross-functional teams to deliver studies on time, within budget, and with high-quality data, with significant responsibility for site startup, training, equipment logistics, data management, and operational issue resolution.Clinical study operations and direct site engagement are core to this role, including travel within the US and occasional international travel as needed. Ability to work in San Carlos, CA or travel frequently to San Carlos is preferred.Responsibilities:Clinical Operations & ExecutionManage end-to-end trial execution for assigned studies, including site identification/feasibility assessment, site initiation and activation, patient enrollment and/or sample acquisition, monitoring oversight, and study close-outOwn and maintain study plans (timelines, milestones, enrollment projections, and operational deliverables) and drive cross-functional execution to meet themCoordinate and oversee CROs and vendors, including scope-of-work support, budget tracking, deliverable review, and issue escalationDrive achievement of study milestones by ensuring timely site activation, high-quality data collection, protocol compliance, and completion of key study deliverables according to established timelinesCoordinate study equipment deployment, shipment, tracking, maintenance, and site logistics in partnership with internal technical and field teamsSupport site management activities, including site communications, site onboarding and training, query resolution, and ensuring timely data entry and documentationEnsure trial compliance and data quality, supporting adherence to protocol, GCP/ICH, applicable regulations, and internal quality standardsContribute to SOPs and process improvements related to site management, monitoring practices, TMF oversight, and data collection workflowsIdentify and escalate operational risks/issues early, propose mitigations, and drive actions to resolution across the study lifecycleCross-Functional Collaboration & Study SupportPartner with Regulatory, Quality, R&D, Biostatistics/Data Science, and Medical Affairs to ensure operational plans align with study objectivesSupport development and maintenance of key trial documents (as applicable), such as:monitoring plans, vendor plans, enrollment planssite training materialsstudy trackers and status dashboardsProvide clear, regular study status updates to internal stakeholders, highlighting progress, risks, and decisions neededQualificationsQualifications:3+ years of hands-on clinical trial operations experience in medical devices or diagnostics with increasing responsibility in trial deliveryExperience coordinating multi-site studies and working effectively with CROs and external vendorsWorking knowledge of GCP/ICH, essential clinical trial documentation, and clinical quality expectations (e.g., TMF completeness, monitoring oversight, audit readiness)Strong project management skills (planning, prioritization, stakeholder management) with the ability to drive execution in a fast-paced environmentEducation: Bachelor’s degree required in life sciences, biomedical engineering, clinical research, or related field; advanced degree a plusPreferred Qualifications:Experience in medical imaging, digital pathology, or image-based clinical workflowsExposure to AI-enabled medical devices (including data collection considerations and performance evaluation concepts)Experience supporting reader studies (site/readers coordination, logistics, training, and data flow)Experience supporting prospective studies in the OR or procedural settingsAdditional InformationDue to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.Mandatory NoticesU.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’sstart date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law.We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.SummaryType: Full-timeFunction: Public RelationsExperience level: AssociateIndustry: Medical Device