Clinical Supply Support Specialist Services - FSP

Clinical Supply Support Specialist Services

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