Project Specialist

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.

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.

• Team Player
• Adaptable
• Detail Oriented
• Problem Solver

• 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 One Drive 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).

• 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
• Ability to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable accommodations considered where appropriate

Location eligibility applies. Candidates must reside in a U.S. state where the company is authorized to hire. This role is not eligible for residents of:
California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia.

• Medical, dental, and vision insurance
• FSA, HSA
• Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
• Group short-term and long-term disability insurance
• Group Life Insurance
• 401K safe harbor plan and company match
• Paid vacation, holiday, sick and volunteer time
• Paid maternity & paternity leave

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 personalized service of a specialized provider.

Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.

WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check outour Linked In Life Page to learn more about our team events and all we do to support our employees.

At WEP Clinical, we look for individuals who are…