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 PA-NPP programs, serve as the central point of contact for the PA-NPP 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 PA-NPP investigators and site staff.
Oversee the PA-NPP program budget and scope of work to ensure on-time, on-budget performance and deliverables according to Clinical Study Agreements.

Bachelor's Degree (In a health or science field preferred)
Prior experience in clinical research, data management, or regulatory affairs, with at least two (2) years of experience in the monitoring and management of clinical research projects is a plus
Computer literacy and proficiency in Microsoft Office
Ability and willingness to travel up to 20% of the time
Strong organizational skills and attention to detail
Excellent written and oral communication skills
Leadership and management skills

Project Manager

Key skills