Clinical Supply Support Specialist Services - FSP
About The Position
Parexel FSP is hiring multiple Clinical Supply Support Specialist Services across the USA. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™
Requirements
- Bachelor’s degree in a related field with an internship or prior industry work experience.
Nice To Haves
- 2+ years of experience in Clinical Supplies
- 2+ years of experience in QA/Regulatory
- 2+ years of experience in Precision Medicine
- 2+ years of experience in Supply Chain
- 2+ years of experience in Manufacturing
- 2+ years of experience in Procurement
- Equivalent research/commercial biopharma experience
Responsibilities
- 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
- Initiate non-system generated shipments
- Monitor and track comparator drug delivery schedules
- Coordinate Depot transfers & site return shipments
- Temperature excursion management and resolution
- 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
- 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
