Logistics Coordinator II

Logistics Coordinator II, Home-based

ICON 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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. Liaise effectively with customs authorities, depots, third-party vendors including courier companies and brokers regarding study shipments, custom clearance, and delivery.
7. Coordinate study supply distribution to study sites (or authorized destinations) and keep project teams informed of shipment status and issues if any.
8. May oversee Depot activities (Study set-up, receptions, inventory management, shipments scheduled, labeling, returns, destruction, and equipment returned).
9. May perform Reconciliation at country level and destruction coordination with the depot.
10. Manage quality issues regarding IP (e.g. - recall, temperature excursions, product technical complaints, local depot issues).
11. Attend study team teleconferences/meetings in relation to clinical trials logistics as needed.
12. Maintain regular tracking on study-related shipments, remaining balance of approved quantity and import/export license validity, as applicable.
13. Support document filing as per ICON SOPs and study requirements.
14. Be familiar with ICH GCP, GxP, relevant ICON SOPs, applicable country legislation and requirements regarding import/export activities and provide country-specific logistics expertise to project teams.
15. 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.
16. For existing equipment at site to collaborate with local monitoring team to make sure that calibration documentation available, as applicable.
17. 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.
18. Work independently on tasks and assignments with minimal to no supervision.
19. Interact directly with the customer on questions of import/export processes.
20. Provide trainings to junior staff and other departments as assigned.
21. May be required to have a basic knowledge of import/export processes in additional countries.
22. Engage in process improvement initiatives.
23. Support other study startup 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).
24. Travel (approximately 5%) domestic and/or international.

Benefits of Working in ICON:

Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfill your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.