Clinical Trial Manager - Italy (Milan) - Infectious Disease / Immunology
Core
Manage day-to-day operations of clinical trials for biotech/pharma companies in Infectious Disease and Immunology therapeutic areas, ensuring compliance with ICH/GCP and serving as the primary sponsor contact.
Role type
Senior Clinical Trial Manager (Infectious Disease/Immunology)
Builds
Clinical trial projects for biotechnology and pharmaceutical clients
Domain
Clinical Research / Biopharma / Infectious Disease / Immunology
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, Clinical trial management systems (implied)
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
Seniority
Mid-to-Senior, hands-on IC