Clinical Supply Support Specialist Services - Spain - FSP

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel are currently recruiting for an Clinical Supply Support Specialist Services to join one of our growing sponsors in Spain. Key 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 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 Years of Experience: Minimum education requirements: Bachelor s degree in a related field with an internship or prior industry work experience. 2+ years of experience in the following fields: • Clinical Supplies • QA/Regulatory • Precision Medicine • Supply Chain • Manufacturing • Procurement • Or equivalent research/commercial biopharma experience If you are interested, please apply or send your CV to [email protected] Originally posted on Himalayas