CTM - FSP - Germany
Core
Manage clinical operational and quality aspects of low to moderate complexity studies to achieve final clean data deliverables within contractual timeframes.
Role type
Senior Clinical Trial Manager (CTM)
Builds
Clinical deliverables (clean data) for customers
Domain
Clinical research / Life Sciences
Required skills
Clinical monitoring, ICH GCP compliance, resource management, budgeting, regulatory submissions, team leadership, project tracking
Preferred skills
Clinical Study Manager (CSM) responsibilities, Accompanied Field Visits (AFVs), financial forecasting
Technologies
Outlook, Excel, Word, automated clinical systems
Responsibilities
Develop clinical tools (Monitoring Plan, Guidelines), manage Trial Master File, coordinate start-up and regulatory submissions, monitor clinical trials and query resolution, conduct field visits, manage team and resources
Seniority
Senior, hands-on IC
