Clinical Supply Support Specialist Services - FSP

Clinical Supply Support Specialist Services - FSP Primary Location: United States, New Jersey, Client Onsite Job ID R0000041238 Category Clinical Logistics About this Role Parexel FSP is hiring multiple Clinical Supply Support Specialist Services .The position will be office based in Warren, New Jersey. 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 management and UAT activities IP / Ancillary Supplies Compatibility Review  Receive and triage request, forward to FDG for review  Perform internet searches and contact manufacturers for information  Data entry of information into database (ASIST or spreadsheet) and Teams Clinical Supply Systems  Manage CSS Email Inbox  Manage IRT system access for users for all studies  Complete EDL, IRR and StiL reviews every 3 months for all studies  Manage all TMF documentation uploads into VEEVA  Assist in UAT testing Minimum education requirements: Bachelor’s degree in a related field with an internship or prior industry work experience. Preferred 2+ years of experience in the following fields: • Clinical Supplies • QA/Regulatory • Precision Medicine • Supply Chain • Manufacturing • Procurement • Or equivalent research/commercial biopharma experience EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.