Associate Director, Clinical Trial Management
Core
Manage day-to-day operations of clinical trials for biotech and pharmaceutical clients, ensuring compliance with ICH/GCP regulations and serving as the primary sponsor contact.
Role type
Senior IC clinical trial manager (project lead)
Builds
Clinical trial studies across Oncology, Cardiovascular, Renal, and other therapeutic areas
Domain
Clinical research / Biotechnology / Pharmaceuticals
Required skills
Clinical trial management, protocol development, risk assessment, vendor management, site quality monitoring, cross-functional team leadership, regulatory compliance (ICH/GCP)
Preferred skills
Advanced degree in health-related field, experience in Phases 2-3, bid defense experience
Technologies
Clinical trial management systems (CTMS), electronic data capture (EDC), statistical software
Responsibilities
Manage and provide accountability for day-to-day operations of the project, Serve as primary Sponsor contact for operational project-specific issues, Review and provide input for study protocol and final study report, Develop operational project plans, Manage risk assessment and execution, Manage study vendors and site quality
Seniority
Senior, hands-on IC with management responsibilities