Clinical Trial Manager

The 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 & Execution

• Manage 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-out
• Own and maintain study plans (timelines milestones enrollment projections and operational deliverables) and drive cross-functional execution to meet them
• Coordinate and oversee CROs and vendors including scope-of-work support budget tracking deliverable review and issue escalation
• Drive achievement of study milestones by ensuring timely site activation high-quality data collection protocol compliance and completion of key study deliverables according to established timelines
• Coordinate study equipment deployment shipment tracking maintenance and site logistics in partnership with internal technical and field teams
• Support site management activities including site communications site onboarding and training query resolution and ensuring timely data entry and documentation
• Ensure trial compliance and data quality supporting adherence to protocol GCP/ICH applicable regulations and internal quality standards
• Contribute to SOPs and process improvements related to site management monitoring practices TMF oversight and data collection workflows
• Identify and escalate operational risks/issues early propose mitigations and drive actions to resolution across the study lifecycle

Cross-Functional Collaboration & Study Support

• Partner with Regulatory Quality R&D Biostatistics/Data Science and Medical Affairs to ensure operational plans align with study objectives
• Support development and maintenance of key trial documents (as applicable) such as:
  • monitoring plans vendor plans enrollment plans
  • site training materials
  • study trackers and status dashboards
• Provide clear regular study status updates to internal stakeholders highlighting progress risks and decisions needed

Qualifications :

Qualifications:

• 3 years of hands-on clinical trial operations experience in medical devices or diagnostics with increasing responsibility in trial delivery
• Experience coordinating multi-site studies and working effectively with CROs and external vendors
• Working 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 environment
• Education: Bachelors degree required in life sciences biomedical engineering clinical research or related field; advanced degree a plus

Preferred Qualifications:

• Experience in medical imaging digital pathology or image-based clinical workflows
• Exposure 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 settings

Additional Information :

Due 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 Notices

U.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 governments 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 employeesstart 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 candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates 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.

Remote Work :

No

Employment Type :

Full-time