Clinical Trial Manager
Core
Lead and oversee clinical research operations across multiple studies, ensuring quality, regulatory compliance, and patient safety from feasibility to closeout.
Role type
Senior Clinical Trial Manager
Builds
Clinical research programs for sponsors and CROs
Domain
Healthcare / Clinical Research
Required skills
Clinical trial lifecycle management, regulatory compliance (GCP, FDA, HIPAA), study budgeting, team leadership, site initiation, participant recruitment, data monitoring, adverse event reporting, SOP development, audit preparation
Preferred skills
Experience with Electronic Data Capture (EDC), ClinicalTrials.gov registration, Corrective and Preventive Actions (CAPAs), vendor management
Technologies
EDC systems, ClinicalTrials.gov
Responsibilities
Evaluate study feasibility with PIs, prepare IRB applications and informed consent forms, negotiate study budgets, oversee daily study execution and compliance, manage participant recruitment and retention, monitor source documentation and resolve queries, report adverse events, supervise research staff, coordinate regulatory inspections, manage study supplies and equipment, prepare performance reports
Seniority
Senior, hands-on IC
