Clinical Team Manager (CTM) - FSP
Core
Manage clinical operational and quality aspects of low to moderate complexity studies to achieve final clean data deliverables within contractual timelines.
Role type
Senior Clinical Team Manager (CTM)
Builds
Clinical trial deliverables (clean data) for pharmaceutical/biotech customers
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Clinical monitoring, ICH GCP compliance, resource management, budgeting, regulatory submissions, team leadership, project tracking, CRF management, ethics committee coordination
Preferred skills
Clinical Study Manager (CSM) responsibilities on small projects, Accompanied Field Visits (AFVs), financial forecasting
Technologies
Outlook, Excel, Word, automated clinical systems
Responsibilities
Develop clinical tools (Monitoring Plans, Guidelines), manage Trial Master File setup, lead team meetings and training, monitor clinical activity timelines and metrics, coordinate start-up activities and regulatory submissions, communicate with study sites on protocol issues
Seniority
Senior, hands-on IC with team management