Responsibilities

Clinical Supply & Inventory Planning & Execution; Supply monitoring, assessment and oversight activities (risks, stocking levels, trends); Pull relevant data for metrics reporting & maintain metrics; Process requisitions and ensure timely procurement of comparator drugs & ancillary supplies; Track and manage comparator documentation updates; Clinical Supply Shipments; Initiate non-system generated shipments; Monitor and track comparator drug delivery schedules; Coordinate Depot transfers & site return shipments; Temperature excursion management and resolution; Clinical Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF); Expected Document List (EDL) creation; Update comparator IMN (Item Master Number); Update and maintain eTMF Document Management per regulatory requirements; Request QA/QP Releases; Pack-and-label kit and sequence reconciliation; Inspection Readiness activities; IRT management activities, including IRT Alert m...