Project Manager - Expanded Access Programs

Project Manager - Expanded Access Programs

• 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