Clinical Trial Manager (Contract)
Core
Manage day-to-day operations of Phase 1-3 clinical trials, including startup, conduct, and close-out, serving as the primary contact for protocol execution and oversight of CROs and study service providers.
Role type
Senior Clinical Trial Manager (Contract)
Builds
Clinical trial deliverables for late-stage biotechnology product candidates (retinal vascular diseases, cystic fibrosis)
Domain
Biotechnology / Clinical Research / Ophthalmology
Required skills
Clinical trial management, Protocol execution, CRO oversight, Regulatory compliance (ICH GCP), Budget management, Site selection, Data review, Contract negotiation, TMF management, Risk mitigation
Preferred skills
Retina clinical trial experience, Global APAC experience, MS Project proficiency
Technologies
Microsoft Office Suite, MS Project
Responsibilities
Serve as primary contact for managing protocol execution and oversight of CROs; Lead cross-functional study execution team; Ensure trials are managed in accordance with ICH GCP and regulations; Assist in preparation and review of clinical trial documentation; Participate in service provider selection; Manage clinical trial budgets and negotiate site contracts; Perform site visits including qualification, initiation, monitoring, and close-out; Oversee outsourced monitoring and review of reports; Track and review protocol deviations.
Seniority
Senior, hands-on IC