Clinical Supply Support Specialist Services - FSP

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is hiring multiple Clinical Supply Support Specialist Services.

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