Clinical Supply Support Specialist Services - Spain - 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 are currently recruiting for an Clinical Supply Support Specialist Services to join one of our growing sponsors in Spain.

Key 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

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 Years of Experience:

Minimum education requirements:

Bachelor’s degree in a related field with an internship or prior industry work experience.

2+ years of experience in the following fields:

• Clinical Supplies

• QA/Regulatory

• Precision Medicine

• Supply Chain

• Manufacturing

• Procurement

• Or equivalent research/commercial biopharma experience

If you are interested, please apply or send your CV to [email protected]

Originally posted on Himalayas