Expanded Access Program Specialist

5 hours ago

London, Greater London, United Kingdom WEP Clinical Inc. Full time
Job Overview:

We are seeking an experienced and detail-oriented individual to join our team as a Academic Specialist for English. This is a key role in our project operations team, responsible for the operational and administrative support of the setup, implementation, and management of Expanded Access Programs (EAPs), Open-Label Extension Studies (OLE), and Post Approval Named Patient Programs (PA-NPP).

Salary: The estimated salary for this position is $70,000 - $90,000 per year, depending on location and experience.

Key Responsibilities:

This role involves working closely with our project management team to ensure projects are completed in accordance with client expectations, coordinating and dispatching shipments of investigational products, and assisting with the development and execution of clinical research programs. You will also be responsible for maintaining, organizing, and reviewing electronic trial master files, clinical trial management systems, and supporting the team in exceeding client expectations.

Responsibilities:
  • Develop and execute clinical research programs, including expanded access and post approval named patient programs
  • Work with the project management team to ensure projects are completed in accordance with client expectations
  • Coordinate and dispatch shipments of investigational products according to the WEP Clinical SOP's
  • Support the project team and finance team with filing vendor invoices for Expanded Access Programs
  • Maintain the sponsor and site contact list
  • Communicate with sites for EAP enrolment and maintenance as needed
  • Organize and maintain shared program-level documents within internal OneDrive or SharePoint
  • Collect and review project documentation from investigational sites, ensuring they meet FDA/GCP/ICH requirements
  • Prepare Investigational Product Review Forms (IPRFs) and submit to WEP Clinical Regulatory team
  • Support preparation of study files based on project scope including maintenance of internal or external document storage systems including Electronic Trial Master File (eTMF)
  • Enter and maintain program, site, and patient-level data into the EAP Clinical Trial Management System (CTMS)

Requirements:

To succeed in this role, you will need:

Education:
  • Bachelor's degree (In a health or science field preferred)
Experience:
  • 1-3 years' experience in project management or clinical research
Skills:
  • Excellent communication and organizational skills
  • Proficiency in Microsoft Office and clinical trial management systems
  • Ability to handle confidential information with complete discretion
  • Strong attention to detail and ability to prioritize tasks effectively

Our Culture:

At WEP Clinical Inc., we value our employees and strive to create a positive and inclusive work environment that supports their growth and development. We offer ongoing training and professional development opportunities, regular recognition and reward for outstanding performance, and a smoke-free, drug-free, and alcohol-free work environment.

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