Clinical Trial Manager (Nephrology)
Core
Manage day-to-day operations of clinical trials in the Nephrology therapeutic area, ensuring compliance with ICH/GCP and serving as the primary sponsor contact for operational issues.
Role type
Senior Clinical Trial Manager (Nephrology)
Builds
Clinical trial studies for biotechnology and pharmaceutical companies
Domain
Clinical Research / Nephrology
Deliverable
client delivery
Required skills
Clinical Trial Management, Protocol development, Risk assessment, Vendor management, Site quality oversight, Project timeline management
Preferred skills
CRO experience, Phases 2-3 trial experience, Bid defense experience, Advanced degree in health/life sciences
Technologies
ICH/GCP guidelines
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 site quality including supervision of Clinical Research Associates