Clinical Supply Support Specialist Services - 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 FSP is hiring multiple Clinical Supply Support Specialist Services. 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

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