Clinical Supply Support Specialist Services - FSP
Behavioral Health Market Context
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Qualifications
- •Bachelor’s degree in a related field with an internship or prior industry work experience
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
- •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
- •23 more items(s)