Project Manager, Clinical Supply

The WEP Clinical Project Manager, Clinical Supply is responsible for the oversight, planning, coordination, and distribution of clinical supplies for Expanded Access Programs (EAP) and other clinical research programs. May also serve as a Project Manager for EAPs. Review trial protocols to understand clinical supply and demand requirements and develop efficient, low-risk supply strategies. Forecast, monitor, and report inventory levels at depots and sites; take proactive steps to prevent shortages or overages. Develop packaging and supply plans that align with project needs and minimize waste. Coordinate global shipments with internal teams and local vendors, ensuring timely delivery. Collaborate with Project Management, Regulatory, Logistics, and Quality teams to align supply chain with study timelines. Lead internal and external meetings, including teleconferences and study Kick Offs. Support development and testing of IRT systems and participate in user requirement specifications. Set up, maintain, and close out CTMS and eTMF systems; conduct routine audits to ensure data accuracy and regulatory compliance. Manage projects from startup to close-out, including expanded access and post-approval programs, while tracking timelines and deliverables. Serve as the main contact for clients and vendors; provide updates and maintain project trackers. Review and process site payments and client invoices; ensure financial accuracy and compliance with study agreements. Supervise and train internal team members, provide protocol training to site staff, and support QA activities including audits and CAPAs.