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Summary
Department:
Facilities Management
Organizational Relationships:
Reports to the Facilities Manager and coordinates all activities related to clinical trial supply chain management within the US and internationally.
This position ensures compliance with international and US laws related to transportation of biological material and any import/export activity and maintains relevant paperwork is filed in accordance with regulatory and study requirements.
Position Overview:
Manage all clinical study shipping logistics in conjunction with SOP’s and process maps:
Utilize the FedEx InSight™ online portal to track shipments to ensure timely delivery;
Prepare all shipping labels for shipments of product doses and procurement shippers to U.S. and international clinical sites and blood collection centers;
Train clinical sites and blood procurement centers to utilize the FedEx InSight system correctly;
Prepare and coordinate mock shipments to new clinical sites prior to site activation and resolve issues; and
Initiate proper action for logistical outliers.
Oversee ImmForm scheduling logistics for clinical trial product shipments, including scheduling changes and updates, for clinical sites, procurement centers and the Company’s internal logistic operations.
Monitor Laboratory Information Management System for shipping logistic discrepancies with ImmForm;
Report issues to clinical management for identification and resolution; and
Act as an ImmForm resource by addressing questions and troubleshooting issues.
Maintain scheduling changes and updates with the Specimen Information and Process Scheduler.
Maintain site list for shipment of Investigational Product.
Monitor and track inventory of dosing and procurement shippers.
Liaise with internal and external constituents to enhance supply chain management activities.
Minimum Education and/or Experience Required:
Experience overseeing a supply chain process and shipping logistics in conjunction with a clinical trial and/or a specialty pharmaceutical environment.
Associates degree with a minimum 3 years of relevant work experience
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