Clinical Supply Support Specialist Services - FSP
Role details
Job location
Tech stack
Job description
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
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