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Logistics Coordinator II - US, 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 fulfil 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 organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Job description:

The Logistics Coordinator II will be responsible for the coordination of Investigational Medicinal Product (IMP), Auxiliary Medicinal Product (AxMP), Medical Devices (MD), Electronic Equipments (EE), Laboratory Kits, and associated activities for each study. This responsibility entails ensuring that reception, handling, storage, distribution, reconciliation, returns (if applicable), and destruction operations are conducted promptly and in accordance with the standards such as ICH GCP, ICON SOPs as well as local and international regulations.

They may also be responsible for assignment of work to other Logistic Coordinators, provide training and mentoring to junior staff and other departments as needed. They may interact directly with customers/clients as required.

• 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

• 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, GxP, 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

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 fulfil 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.

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.

What ICON can offer you:

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

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family’s needs.

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

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 or submit a request here (https://careers.iconplc.com/reasonable-accommodations)

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply