.Logistics Coordinator II, Home-basedICON plc is a world-leading healthcare intelligence and clinical research organization.
We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.At ICON, it's our people that set us apart.
Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership, and Integrity.
We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point.
In short, to be the partner of choice in drug development.Job Description:Coordinate the process to allow import and export of clinical study supplies (may include but not limited to, Investigational Medicinal products (IMP), AxMP, medical device, laboratory kits, and equipment): request, compile, complete and/or review necessary documentation, request import/export license approval from competent authorities as applicable; interact with couriers,brokers, and customs authorities.Prepare and submit initial import/export license applications, amendments and/or renewals to competent authorities in accordance with protocol, pharmacy/laboratory manuals and/or study-specific requirements, as applicable.Create and/or review pro forma/commercial invoices and any other relevant documentation for import and/or export, in accordance with local country requirements and client specifications, as applicable.Review and request required changes to pro forma/commercial invoices or any other relevant documentation, to ensure accuracy and completeness; provide approval for shipments as applicable.Liaise effectively with Clinical team - CTM/PM/CRA and/or CSCO teams (CSSM & Distribution team) to ensure country-specific requirements are noticed and discussed prior to study-related shipments.Liaise effectively with customs authorities, depots, third-party vendors including courier companies and brokers regarding study shipments, custom clearance, and delivery.Coordinate study supply distribution to study sites (or authorized destinations) and keep project teams informed of shipment status and issues if any.May oversee Depot activities (Study set-up, receptions, inventory management, shipments scheduled, labeling, returns, destruction, and equipment returned).May perform Reconciliation at country level and destruction coordination with the depot.Manage quality issues regarding IP (e.G.
- recall, temperature excursions, product technical complaints, local depot issues).Attend study team teleconferences/meetings in relation to clinical trials logistics as needed