Clinical Trial Manager

Responsibilities

• 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
• Support 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

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
• Bachelor’s degree required in life sciences, biomedical engineering, clinical research, or related field; advanced degree a plus
• Preferred qualifications include 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), and experience supporting prospective studies in the OR or procedural settings