Jobless Developer
WEP Clinical logo
WEP Clinical

Posted 1 month ago

Open

Project Specialist

Chiswick, LondonHybridFull-time

AI Summary

Supports the operational and administrative setup of Expanded Access Programs (EAPs), maintaining trial master files, coordinating shipments, and ensuring compliance with FDA/GCP/ICH requirements.

About this role

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical and play a vital role in the successful management of Expanded Access Programs (EAP). We challenge our team to bring thought-provoking ideas to the table and to help define and drive solutions for clients and patients. Join us in our mission to improve patient outcomes and make a difference in the field of clinical research.
Role Objectives:
As a Project Specialist at WEP Clinical, you will be responsible for the operational and administrative support of the setup, implementation, and management of Expanded Access Programs (EAPs). Your responsibilities will include maintaining, organizing, and reviewing electronic trial master files, clinical trial management systems, and supporting the team in exceeding client expectations.

The Ideal Candidate:

  • Team Player
  • Adaptable
  • Detail Oriented
  • Problem Solver

    • What You'll Do:

  • Assist with the development and execution of EAPs.
  • Work with the project management team to ensure projects are completed in accordance with client expectations.
  • Work with the supply chain team to 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 EAPs.
  • Maintain the sponsor and site contact list.
  • Communicate with sites for EAP enrollment and maintenance as needed.
  • Organize and maintain shared program-level documents within internal OneDrive or SharePoint.
  • Assist with project documentation collection and review 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).

    • What You'll Need:

  • Bachelor’s degree (In a health or science field preferred)
  • 1-3 years’ experience in project management or clinical research
  • Effective verbal and written communication skills
  • Computer literacy and proficiency in Microsoft Office
  • Ability to handle confidential information with complete discretion
  • Strong organizational skills and attention to detail

    • Skills

    Clinical Trial Management System (CTMS)Electronic Trial Master File (eTMF)FDAGCPICHMicrosoft OfficeOneDriveSharePoint

    Explore related jobs

    More jobs at WEP Clinical

    Similar FDA jobs

    Jobs in Chiswick

    Browse these categories

    GCP JobsMicrosoft Office JobsSharePoint JobsJobs in LondonJobs in United Kingdom

    Market data for this role

    All reports →