FSP CTM
Core
Manages clinical operational and quality aspects of low to moderate complexity studies, ensuring compliance with ICH GCP and delivering final clinical deliverables within contractual timelines.
Role type
Senior Clinical Trial Manager (CTM)
Builds
Clinical trial operations and deliverables for global health research
Domain
Clinical research / Life sciences
Deliverable
client delivery
Required skills
Clinical monitoring, ICH GCP compliance, resource management, budgeting and forecasting, regulatory submissions, team leadership, project tracking, document quality control
Preferred skills
Clinical Study Manager (CSM) responsibilities, accompanied field visits (AFVs), CRF design, ethics committee interaction
Technologies
Outlook, Excel, Word, tracking and management tools
Responsibilities
Manage clinical operational and quality aspects of allocated studies; Develop clinical tools and contribute to Master Action Plan; Collaborate with clinical team to meet project deliverables; Monitor clinical trials and manage CRF collection; Coordinate start-up activities and regulatory submissions; Provide input into forecast estimates and manage clinical resources.
