Expanded Access Manager – Post-Trial Access Specialist

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Establish and oversee operational support for post-trial managed access programs from inception to conclusion.

• Manage budgets, clinical trial management systems, vendor communications, investigational product inventory and distribution, documents, agreements, contracts, and correspondence.

• Collaborate with clinical study teams to evaluate feasibility, regulatory needs, logistics, and supply strategies.

• Partner with global and local medical affairs, clinical operations, and cross-functional stakeholders.

• Provide daily support to ensure uninterrupted access for post-trial patients.

• Monitor program status, investigational product management, documentation, and data review activities in accordance with regulatory standards and Good Manufacturing Practices.

• Oversee vendors involved in program execution.

• Coordinate expanded access initiatives, including document collection, filing, archiving, timelines, and metrics.

• Deliver program status and utilization updates to stakeholders.

• Assist in clinical supply planning and forecasting in collaboration with CMC and other functional teams.

• Create project materials and operational communication resources.

• Identify delivery challenges and risks, coordinate corrective strategies, and communicate with stakeholders.

• Monitor milestones and timelines, contributing to program initiatives and process enhancements.

⛳️ Requirements

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

• A minimum of 3 years of pertinent experience in the pharmaceutical, biotechnology, clinical research, or CRO industry.

• Direct experience in clinical research or managed access, such as a study manager, Clinical Research Associate (CRA), project manager, or similar role.

• Familiarity with compassionate use, early access, or expanded access programs.

• Demonstrated ability to work effectively within cross-functional teams.

• High standards of integrity, accuracy, and attention to detail.

• Strong organizational, prioritization, and project management capabilities.

• Proven ability to complete assignments on time and within budget.

• Excellent problem-solving skills and sound judgment.

• Exceptional written and verbal communication abilities.

• Understanding of cross-functional responsibilities across Supply Chain, Regulatory, Pharmacovigilance, Legal, Medical Writing, and local medical teams.

• Capacity to manage multiple workstreams, stakeholders, vendors, and deliverables.

• Ability to interpret operational and regulatory requirements and translate them into actionable program plans.

• Skill in clearly communicating risks, status, timelines, and actions to internal and external stakeholders.

• Dedication to quality, compliance, and continuous improvement.

🏝️ Benefits

• Full-time employment.

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.