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 marta.kuniewicz@parexel.com
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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