What are the responsibilities and job description for the Clinical Supply Support Specialist Services - FSP position at Parexel?
Parexel FSP is hiring multiple Clinical Supply Support Specialist Services .The position will be office based in Warren, New Jersey.
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 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