When our values align, there's no limit to what we can achieve.
Key Responsibilities:
Clinical Supply & Inventory Planning & Execution
1. Supply monitoring, assessment and oversight activities (risks, stocking levels, trends)
2. Pull relevant data for metrics reporting & maintain metrics
3. Process requisitions and ensure timely procurement of comparator drugs & ancillary supplies
4. Track and manage comparator documentation updates
Clinical Supply Shipments
5. Initiate non-system generated shipments
6. Monitor and track comparator drug delivery schedules
7. Coordinate Depot transfers & site return shipments
8. Temperature excursion management and resolution
Clinical Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF)
9. Expected Document List (EDL) creation
10. Update comparator IMN (Item Master Number)
11. Update and maintain eTMF Document Management per regulatory requirements
12. Request QA/QP Releases
13. Pack-and-label kit and sequence reconciliation
14. Inspection Readiness activities
15. IRT management activities, including IRT Alert management and UAT activities
IP / Ancillary Supplies Compatibility Review
16. Receive and triage request, forward to FDG for review
17. Perform internet searches and contact manufacturers for information
18. Data entry of information into database (ASIST or spreadsheet) and Teams
Clinical Supply Systems
19. Manage CSS Email Inbox
20. Manage IRT system access for users for all studies
21. Complete EDL, IRR and StiL reviews every 3 months for all studies
22. Manage all TMF documentation uploads into VEEVA
23. 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.
Preferred
2+ years of experience in the following fields:
24. Clinical Supplies
25. QA/Regulatory
26. Precision Medicine
27. Supply Chain
28. Manufacturing
29. Procurement
30. Or equivalent research/commercial biopharma experience