Expanded Access Manager​/Post-Trial Access Specialist - FSP - UK

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.

• 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.
• Collaborate with CMC and other functional areas to support clinical supply planning and forecasting as requested by program leads.
• Develop project materials and tools that enable effective operationalization and communication.
• Proactively identify delivery issues and risks, coordinate corrective actions when deviations occur and communicate appropriately with stakeholders.
• Track key milestones and timelines and contribute to program initiatives and process improvements.

• Proven ability to work effectively in cross-functional teams and contribute to shared goals.
• High level of integrity, accuracy and attention to detail.
• Strong organizational, prioritization and project management skills, with the ability to deliver assignments on time and within budget.
• Strong problem-solving skills and sound judgment in an environment where priorities may evolve.
• Excellent written and verbal communication skills, with the ability to work effectively with stakeholders at different levels and across functions.
• Self-motivated, resourceful and results-oriented, with the ability to work with urgency in a fast-paced environment.
• Understanding of cross-functional responsibilities across areas such as Supply Chain, Regulatory, Pharmacovigilance, Legal, Medical Writing and local medical teams.

Bachelor’s degree in a scientific or clinical discipline, or equivalent relevant education and experience.

• At least 3 years of relevant experience in the pharmaceutical, biotechnology, clinical research or CRO industry.
• Direct experience in clinical research or managed access, for example as a study…