Do you want to be a part of a team that gives hope to patients with rare and life-threatening diseases? Are you looking for career growth, challenges, or a more motivating role? At WEP Clinical, our business is growing, and the career opportunities are endless. Our Project Managers’ help patients get early access to medicine every day. We challenge our team to bring thought-provoking ideas to the table. Join us and see the impact you can make!

ROLE OBJECTIVES:

As a Project Manager, you will play a vital role in getting medicines to patients who have exhausted all viable options. You will be responsible for the setup, implementation, and management of individual Expanded Access Programs.

WHAT YOU’LL DO:

• Manage the development, execution, and close-out of clinical research programs, including expanded access, managed access, and compassionate use programs
• Execute project plans for new EAP programs, serve as the central point of contact for the EAP client and 3rd party vendors, and assist the drug safety team per the project-specific safety management plan
• Setup & close-out of the Clinical Trial Management System (CTMS), and the Electronic Trial Master File (eTMF), prepare study files based on project scope including maintenance of internal or external document storage systems and maintain program, site, and patient-level data into the CTMS
• Senior oversight of the supply chain team to coordinate and dispatch shipments of investigational products
• Lead internal and external teleconferences, project Kick Off Meetings, and weekly check-ins with project team members
• Liaise with the Quality Assurance team to initiate and conduct program-related investigations, CAPAs, and conduct routine audits as well as submit and perform central IRB applications
• Oversee the development of project-level documentation and CRFs, ensuring updates are made as needed throughout the program
• Supervise, train, and mentor internal applicable project team members, and provide protocol-related training to EAP investigators and site staff
• Oversee the EAP program budget and scope of work to ensure on-time, on-budget performance and deliverables according to Clinical Study Agreements