Clinical Supply Coordinator

The Clinical Supply Coordinator provides support to the Clinical Trial Supplies team to support the on-time delivery of supplies (Investigational Medicinal Products and Non-Investigational Medicinal Products) to clinical sites for established clinical trials contracted to IQVIA. This is achieved through supporting the Associate Clinical Supply Chain Manager or Clinical Supply Chain Manager with effective inventory monitoring, ongoing forecasting of drug demand, initiation and delivery of packaging campaigns and a strong distribution strategy. The Clinical Supply Coordinator will ensure quality compliance, file documentation according to regulatory requirements, manage some finance aspects and general coordination of meetings, communications, tracking and inbox monitoring.

Essential Functions

1. Ability to work independently and proactively to ensure that the supply of all trial materials is delivered to the right place at the right time.
2. Support maintenance of demand forecasts and packaging plans so that packed clinical supplies are readily available in accordance with the project requirements.
3. Assist in planning and paperwork for packaging campaigns with the assigned vendor and provide support to ensure on-time delivery.
4. Manage vendor Work Order, Change Order and Purchase Order progression upon Clinical Supply Chain Manager approval to move forward with quote.
5. Monitor, and where necessary, update study assigned Interactive Response Technology (IRT) systems to ensure study inventory is effectively managed.
6. Support the Clinical Supply Chain Manager with the execution of a clinical supply plan.
7. Provide ongoing budget tracking activities so that projects are run efficiently and in accordance with client approved quotations.
8. Provides administration support to the Clinical Trial Supplies team where required.
9. Participate in client and vendor related meetings where necessary to discuss Clinical Supply Chain topics or status updates.
10. Remain up to date in all GxP and regulatory requirements applicable to the role.
11. Maintains 100% compliance on all assigned training and applies learnings to everyday practice.
12. SOP, Project Instruction, Work Instruction creation and updates.
13. Monitor shared mailboxes.
14. Second person verification checks for specified processes.
15. Manage communications between vendor and IQVIA where applicable including capture of meeting minutes etc.
16. Provides administration to support Clinical Supply Chain Manager with Temperature Excursions reported to the IQVIA Clinical Trial Supplies team.
17. Be responsible for and a subject matter expert in the IQVIA resource hours reporting process (EAC).

Education

High School Diploma or equivalent.

Additional Work Experience

Typically requires 0 - 2 years of prior relevant experience. 0-2 Years related industry experience in Clinical Trials or Pharmacy (Preferred not essential). 0-2 Years related experience in Clinical Supplies – this could be from Supply Chain, Packaging, Distribution or IRT functions (Preferred not essential).

Skills and Abilities

1. Demonstrated project management skills.
2. Ability to build strong customer relationships.
3. Proficient in English written and verbal communication skills.
4. Proficient in Microsoft Office (Word, Excel, Powerpoint etc.).
5. Demonstrated problem-solving skills.