Project Specialist
Job description
A Project Specialist role at WEP Clinical providing operational and administrative support for the setup, implementation, and management of Expanded Access Programs (EAPs). The role involves documentation, data entry, and coordination with project, supply chain, finance, and regulatory teams.
At a glance
- Work mode
- Remote
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 we're looking for
- 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
- Team Player
- Adaptable
- Detail Oriented
- Problem Solver
Benefits
- Group Private Medical Insurance
- Group General Life Assurance
- Group Critical Illness and Group Income Protection
- Salary sacrifice pension scheme
- Enhanced maternity & paternity pay
- Educational Assistance allowance
- Paid volunteering day
Apply
Direct apply at WEP Clinical
Opens the job posting at WEP Clinical
About WEP Clinical
WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalised service of a specialised provider.
Mission
To improve patient outcomes and make a difference in the field of clinical research.
Key facts
- More than 15 years of global experience
- Supported programs across 150+ countries
What they value
- Integrity
- Accountability
- Respect for diverse perspectives