Manager, Clinical Operations
Core
Lead and manage a team of Clinical Project Managers to oversee the planning, execution, and closeout of complex, global multicenter clinical studies for medical technology products.
Role type
Senior IC Clinical Operations Manager (Specimen Management)
Builds
Clinical study deliverables including protocols, reports, and Trial Master Files for Medical Affairs and CRO-conducted studies
Domain
Medical Technology / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study management, Team leadership, Project management, Regulatory compliance (ICH-GCP), Budget forecasting, Risk mitigation, Vendor/CRO management, TMF oversight
Preferred skills
Advanced degree (MS/MBA/PhD), PMP certification, People management experience, Technical/medical writing
Technologies
Microsoft Office Suite (Excel, Word, PowerPoint, Teams)
Responsibilities
Lead and develop a team of Clinical Project Managers; Establish team objectives and monitor performance; Provide oversight for study documents (protocols, CRFs, safety plans); Oversee resource allocation and budget forecasts; Lead continuous improvement and audit investigations; Foster relationships with sites/PIs and vendors; Monitor KPIs and study milestones; Adapt deliverables based on study complexity.
Seniority
Manager, hands-on IC with team leadership
