Clinical Trial Project Manager - Cardiovascular, Renal, Gastrointestinal - Denver
Core
Manage day-to-day operations of clinical trials for Cardiovascular, Renal, and Gastrointestinal therapeutic areas, serving as the primary sponsor contact for operational issues and study deliverables.
Role type
Senior Clinical Trial Project Manager (CRO)
Builds
Clinical trial studies for biotechnology and pharmaceutical companies
Domain
Clinical Research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
Project management, risk assessment, vendor management, site quality management, protocol review, cross-functional oversight, ICH/GCP compliance knowledge
Preferred skills
Advanced degree in health-related field, experience in Phases 2-3 clinical trials
Technologies
Clinical trial management systems, data analysis tools
Responsibilities
Manage and provide accountability for day-to-day operations of the project according to ICH/GCP; Serve as primary Sponsor contact for operational project-specific issues and study 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
Seniority
Mid-Senior level, 3-5 years experience