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 therapeutics targeting retinal vascular diseases and cystic fibrosis
Domain
Biotechnology / Clinical Research / Ophthalmology / Respiratory
Deliverable
client delivery
Required skills
Clinical trial management, CRO oversight, protocol execution, budget management, site contract negotiation, regulatory compliance (ICH GCP), TMF management, site monitoring, risk mitigation, cross-functional collaboration
Preferred skills
Retina clinical trial experience, Global APAC experience, MS Project proficiency, therapeutic area expertise
Technologies
Microsoft Office Suite, MS Project
Responsibilities
Manage trial budgets and negotiate site contracts; oversee outsourced monitoring and resolve site-related issues; coordinate resolution of audit findings; support development of study execution plans and site selection; perform site visits including qualification, initiation, and close-out; track protocol deviations and assess impact on study data.
Seniority
Senior, hands-on IC
