Clinical Trial Manager
Core
Lead Study Start-Up (SSU) activities, planning, and activation deliverables for clinical trials in compliance with GCP/ICH and regulatory requirements.
Role type
Senior Clinical Trial Manager (Study Start-Up)
Builds
Study start-up packages, timelines, and activation deliverables for assigned projects
Domain
Clinical Research / Pharmaceutical / CRO
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Study Start-Up strategy, IRB/IEC submission management, Health Authority engagement, site selection, outsourced study management, team leadership, competing priorities management
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead SSU activities in collaboration with Feasibility and Site Partnership Managers; ensure SSU timelines and deliverables are met; prepare and finalize local submission packages for IRB/IEC and Health Authorities; lead site selection with stakeholders; manage outsourced studies to CROs
Seniority
Senior, hands-on IC