Clinical Supply Support Specialist Services - FSP

Clinical Supply Support Specialist

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 positions. 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 Supplies
• QA/Regulatory
• Precision Medicine
• Supply Chain
• Manufacturing
• Procurement
• Or equivalent research/commercial biopharma experience

EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.