Turkey Job Openings
Icon plc
Logistics Coordinator II
Ankara
FULL TIME
September 25, 2024
- 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
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
#LI-TS3
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Various annual leave entitlements
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A range of health insurance offerings to suit you and your family’s needs.
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Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
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Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
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Life assurance
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Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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