Expanded Access Manager / Post-Trial Access Specialist - FSP - UK
Core
Operational leadership for managed access programs (compassionate use, expanded access, post-trial access) in oncology, ensuring continuity of investigational product supply and regulatory compliance for patients after clinical trials.
Role type
Senior IC Expanded Access Manager / Post-Trial Access Specialist
Builds
Post-trial managed access programs for oncology patients
Domain
Life Sciences / Oncology / Clinical Research Operations
Deliverable
client delivery
Required skills
Cross-functional coordination, regulatory compliance interpretation, vendor management, clinical supply planning, project management, risk identification, document management
Preferred skills
Oncology domain expertise, prior managed access program management experience, CMC collaboration
Technologies
Clinical trial management systems, document management systems
Responsibilities
Manage operational support for post-trial managed access programs from planning to close-out; Collaborate with clinical study teams to assess feasibility and regulatory requirements for managed access; Coordinate investigational product stock, delivery, and document management; Manage vendors supporting program execution; Track key milestones and timelines; Provide program status updates to stakeholders; Identify delivery issues and coordinate corrective actions.
Seniority
Senior, hands-on IC