Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

ROLE OBJECTIVES:

The WEP Clinical Project Specialist is responsible for providing operational and administrative support throughout the setup, implementation, and management of Expanded Access Programs (EAPs). Key responsibilities include maintaining, organizing, and reviewing electronic trial master files (eTMF), managing clinical trial management systems (CTMS), and supporting the team to consistently exceed client expectations.

WHAT YOU’LL DO:

• Assist with the development and execution of clinical research programs, including post-approval named patient programs.
• 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 programs.
• Maintain the sponsor and site contact list.
• Communicate with sites for enrolment and maintenance as needed.
• Organise and maintain shared program-level documents within internal OneDrive or SharePoint.
• Assist with project documentation collection and review from investigational sites.
• Prepare Investigational Product Review Forms (IPRFs) and submit them to the WEP Clinical Regulatory team.
• Supported the 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 Clinical Trial Management System (CTMS).