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
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Supply monitoring, assessment and oversight activities (risks, stocking levels, trends)
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Pull relevant data for metrics reporting & maintain metrics
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Process requisitions and ensure timely procurement of comparator drugs & ancillary supplies
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Track and manage comparator documentation updates
Clinical Supply Shipments
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Initiate non-system generated shipments
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Monitor and track comparator drug delivery schedules
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Coordinate Depot transfers & site return shipments
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Temperature excursion management and resolution
Clinical Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF)
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Expected Document List (EDL) creation
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Update comparator IMN (Item Master Number)
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Update and maintain eTMF Document Management per regulatory requirements
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Request QA/QP Releases
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Pack-and-label kit and sequence reconciliation
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Inspection Readiness activities
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IRT management activities, including IRT Alert management and UAT activities
IP / Ancillary Supplies Compatibility Review
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Receive and triage request, forward to FDG for review
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Perform internet searches and contact manufacturers for information
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Data entry of information into database (ASIST or spreadsheet) and Teams
Clinical Supply Systems
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Manage CSS Email Inbox
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Manage IRT system access for users for all studies
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Complete EDL, IRR and StiL reviews every 3 months for all studies
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Manage all TMF documentation uploads into VEEVA
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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 **managing clinical supplies **
2+ years of experience in the following fields:
Previous experience as Clinical Trial Supplies Associate, Supply Specialist, Quality Assurance Analyst.
If you are interested, please apply or send your CV to marta.kuniewicz@parexel.com