Clinical Trial Project Manager - Cardiovascular, Renal, Gastrointestinal - Cincinnati
Core
Manage day-to-day operations of clinical trials for Cardiovascular, Renal, and Gastrointestinal therapeutic areas, ensuring compliance with ICH/GCP and serving as the primary sponsor contact.
Role type
Senior Clinical Trial Project Manager (CRO)
Builds
Clinical trial studies for biotechnology and pharmaceutical companies
Domain
Clinical Research / Contract Research Organization (CRO)
Required skills
Project management, ICH/GCP compliance, therapeutic area knowledge (Cardiovascular, Renal, GI), cross-functional team leadership, vendor management, risk assessment, site quality management, protocol review
Preferred skills
Advanced degree in health-related field, experience in Phases 2-3 clinical trials
Technologies
Clinical trial management systems, regulatory compliance frameworks
Responsibilities
Manage project operations per contract and regulations, serve as primary sponsor contact, oversee internal project team and training, review study protocols and reports, develop operational plans, manage risk assessment, supervise study vendors, manage site quality and Clinical Research Associates
Seniority
Mid-Senior, hands-on IC with management responsibilities