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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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