USA remote
Expanded Access Manager / Post-Trial Access Specialist - FSP - UK
About this role
Job Title: Expanded Access Manager / Post-Trial Access Specialist - FSP - UK Job Location: Remote, United Kingdom Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. We are seeking an Expanded Access Manager / Post-Trial Access Specialist (Oncology) to provide operational leadership and guidance for managed access programs, including compassionate use, expanded access and post-trial access.
In this role, you will build strong relationships across clinical operations, medical affairs, supply, finance, governance and other cross-functional teams, while supporting effective communication with healthcare professionals, vendors and other external stakeholders. A Day in the Life Set up and manage operational support for post-trial managed access programs from planning through close-out, including budget coordination, clinical trial management systems, vendor communications, investigational product stock and delivery, and tracking of documents, agreements, contracts and key correspondence.
Collaborate with clinical study teams to assess feasibility, regulatory requirements, logistical plans and supply mechanisms for managed access following the close of sponsored clinical trials. Partner with global and local medical affairs, clinical operations and cross-functional stakeholders to deliver post-trial managed access programs. Provide day-to-day coordination to support continuity of access for post-trial patients.
Coordinate program status tracking, investigational product management, document management and data review activities in accordance with applicable regulatory requirements and Good Manufacturing Practice. Manage vendors supporting program execution. Coordinate expanded access activities, including document collection, filing and archiving, and tracking timelines and metrics to support timely, high-quality delivery. Provide regular program status and utilization updates to relevant stakeholders.