Clinical Trial Manager

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:

• 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: Bachelor's 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