Clinical Trial Manager (Immunology)
Core
Lead multiservice global/regional clinical trials for immunology, coordinating all contracted services and managing the timeline and project deliverables from startup to closure.
Role type
Senior Clinical Trial Manager (Immunology)
Builds
Global/regional clinical trials for biotech and pharmaceutical sponsors
Domain
Clinical Research / Immunology
Deliverable
client delivery
Required skills
Clinical trial management, protocol knowledge, risk assessment, vendor management, site quality oversight, cross-functional team leadership
Preferred skills
CRO experience, Asia Pacific region experience, specific therapeutic area indications
Technologies
ICH/GCP regulations
Responsibilities
Manage day-to-day project operations per contract and regulations; Serve as primary Sponsor contact; Maintain in-depth knowledge of protocol and therapeutic area; Provide cross-functional oversight and training; Review study protocol and final study report; Develop operational project plans; Manage risk assessment and mitigations; Manage study vendors; Supervise Clinical Research Associates (CRA) and monitoring deliverables
Seniority
Senior, hands-on IC