Clinical Trial Manager - Expanded Access Programs
Core
Manage operational planning, timelines, budgets, and site selection for clinical trials, specifically focusing on expanded access and post-trial access programs.
Role type
Senior Clinical Trial Manager (Expanded Access Programs)
Builds
Clinical trial programs for biopharmaceutical companies
Domain
Biopharmaceuticals / Clinical Research
Deliverable
client delivery
Required skills
Clinical trial operational management, site feasibility and selection, vendor management, regulatory document review, budget and timeline management, patient recruitment planning, safety monitoring, multi-disciplinary team leadership
Preferred skills
Experience in post-trial access programs, knowledge of ICH GCP, managing complex global programs
Technologies
Clinical trial management systems, regulatory document platforms
Responsibilities
Deliver trials on time and within budget, manage trial timelines and budgets, select and monitor investigative sites, coordinate vendor activities, review monitoring reports, develop recruitment and risk-mitigation plans, participate in data review and safety monitoring, lead multi-disciplinary trial teams
Seniority
Senior, hands-on IC