FSP Bench Clinical Trial Manager
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 Trial Manager (FSP)
Builds
Clinical study deliverables (clean data, TMF, monitoring plans) for pharmaceutical/biotech customers
Domain
Clinical Research / Contract Research Organization (CRO)
Required skills
Clinical monitoring, ICH GCP compliance, resource management, budget forecasting, regulatory submissions, team leadership, query resolution, site coordination
Preferred skills
Clinical Study Manager (CSM) responsibilities, Accompanied Field Visits (AFVs), bid defense preparation
Technologies
Outlook, Excel, Word, automated clinical systems
Responsibilities
Develop clinical tools (Monitoring Plans, MAP), manage trial timelines and metrics, coordinate start-up and regulatory submissions, conduct monitoring visits, manage clinical resources and budgets, lead team meetings
Seniority
Senior, hands-on IC
