Clinical Trial Manager (Nephrology)
Core
Manage day-to-day operations of clinical trials in the Nephrology therapeutic area, serving as the primary sponsor contact for operational issues and study deliverables.
Role type
Senior Clinical Trial Manager (Nephrology)
Builds
Clinical trial projects for biotechnology and pharmaceutical companies
Domain
Clinical Research / Nephrology
Required skills
Clinical Trial Management, Protocol development, Risk assessment, Vendor management, Site quality oversight, Cross-functional team leadership
Preferred skills
CRO experience, Phases 2-3 trial experience, Bid defense experience, Advanced degree in health/life sciences
Technologies
ICH/GCP regulations
Responsibilities
Manage and provide accountability for day-to-day operations of the project, Serve as primary Sponsor contact for operational project-specific issues and study deliverables, Maintain in depth knowledge of protocol, therapeutic area, and indication, Provide cross-functional oversight of internal project team members and deliverables, Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, Develop operational project plans, Manage risk assessment and execution, Responsible for management of study vendor, Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables