Clinical Trial Manager (Oncology/Cardiovascular/Endocrine/Metabolic)
Core
Manage day-to-day operations of clinical trials for biotech and pharmaceutical companies, ensuring compliance with ICH/GCP regulations and serving as the primary sponsor contact.
Role type
Senior Clinical Trial Manager (Oncology/Cardiovascular/Endocrine/Metabolic)
Builds
Clinical trial projects for biotechnology, pharmaceutical, and medical device industries
Domain
Clinical Research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
Clinical Trial Management, Protocol development, Risk assessment, Vendor management, Site quality oversight, Project timeline management, 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 guidelines
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