Clinical Trial Manager, FSP
Core
Manage clinical operational and quality aspects of low to moderate complexity studies to achieve final clean data deliverables within contractual timeframes.
Role type
Mid-level Clinical Trial Manager
Builds
Clinical study deliverables (clean data, TMF, monitoring plans) for customers
Domain
Clinical research / Contract Research Organization (CRO)
Required skills
Clinical monitoring, ICH GCP compliance, Trial Master File management, resource management, budgeting, regulatory submissions, query resolution, team leadership
Preferred skills
Clinical Study Manager (CSM) responsibilities, Accompanied Field Visits (AFVs), bid defense, financial forecasting
Technologies
Outlook, Excel, Word, automated clinical systems
Responsibilities
Manage clinical operational and quality aspects of allocated studies; Develop clinical tools and contribute to Master Action Plan; Collaborate with team to meet project deliverables; Monitor clinical activity timelines and metrics; Coordinate start-up activities and regulatory submissions; Communicate with study sites regarding protocol and patient participation.
Seniority
Mid-level, hands-on IC
