Clinical Supply Support Specialist Services - Spain - FSP

Parexel is a company dedicated to improving global health through clinical trials, regulatory, consulting, and market access solutions. They value empathy, personal commitment, and making a difference in patients' lives.

Location: Spain

Responsibilities

• 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
• Initiate non-system generated shipments
• Monitor and track comparator drug delivery schedules
• Coordinate Depot transfers & site return shipments
• Temperature excursion management and resolution
• 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
• 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
• 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

Requirements

• Bachelor’s degree in a related field with an internship or prior industry work experience.
• 2+ years of experience in Clinical Supplies, QA/Regulatory, Precision Medicine, Supply Chain, Manufacturing, Procurement or equivalent research/commercial biopharma experience.