Logistics Coordinator II, home based, Istanbul Turkey

• Coordinate the process to allow import and export of clinical study supplies (may include but not limited to, Investigational Medicinal products (IMP), Ax MP, 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
• Maintain regular tracking on study related shipments, remaining balance of approved quantity and import/export license validity, as applicable
• Support document filing as per ICON SOPs and study requirements
• Be familiar with ICH GCP, Gx P, relevant ICON SOPs, applicable country legislation and requirements regarding import/export activities and provide country specific logistics expertise to project teams
• Contact the study sites and confirm that information regarding missing equipment provided during PSV is current; inform CTM of missing equipment for site, as applicable
• For existing equipment at site to collaborate with local monitoring team to make sure that calibration documentation available, as applicable
• Be the point of contact for internal/external audits in relation to logistics and supplies, could be assigned as Point of Contact (POC) for country specific question and related tasks
• Work independently on tasks and assignments with minimal to no supervision
• Interact directly with the customer on questions of import/export processes
• Provide trainings to junior staff and other departments as assigned
• May be required to have a basic knowledge of import/export processes in additional countries
• Engage in process improvement initiatives
• Support other study start up activities as assigned (e.g. collaborate on budgets IMP LCSR per study at country level, performs IMP checklist review and validation in SQV and SIV)
• Travel (approximately 5%) domestic and/or international