Logistics Coordinator Ii

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.

The IPS will oversee the management 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 Client's standards as well as local and international regulations. The IPS II may supervise the work of other IPSs, provide trainings to junior staff and other departments as needed, as well as interact directly with customers .

The role:

• Coordinate the process to allow import and export of clinical study supplies (may include but not limited to, Investigational products (IP), non-IPs, 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

• Under the oversight of the Investigational Medicinal Product Manager ensures the day-to-day processing of US CSU IP inventory is as per local SOPs and procedures

• Coordinates and collates the receipt, storage, inventory, shipment, acknowledgment of receipt, return, reconciliation and destruction of IMP/non-IMP with the Warehouse, study Monitoring Teams, CTOMs and external partners

• Ensures the local study files owned by the IP Manager are complete as per local SOPs and are audit ready

• Monitor IP tracking tables (IPTT) or CSMS (Clinical Supply Management System) to ensure ongoing completion by monitoring teams for site shipment and receipt, return and destruction.

• Activity also includes tracking temperature excursions. Provide data entry support as needed for both IPTT & CSMS.

To be successful in the role, you will have:

• At least 3- 6 years of experience and knowledge of the life cycle management of Investigational Medicinal Products (IMP) and non-IMP from receipt to destruction.

• Experience with IVRS, IMP and non-IMP inventory tracking including usage, returns, reconciliation and destruction is desirable. 

• Basic knowledge of Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), CFR, ICH regulations pertaining to IP desirable.

• Experience in warehousing, local import and export processes

• Computer experience with Microsoft Office (especially Excel)

• Bachelor degree

• Advanced English level

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.