What does a typical day in your job involve?
The Project Services department is responsible for the overall delivery of manufacturing and distribution of a drug for a clinical trial. We work with clients to define their specifications and turn these into working instructions for the operational teams to produce a quality product, within the specified time frame. Project Services are in a unique position in that they act as the cohesive group that bring all of the different departments together. We work with Business Development during quoting stages, and then Production and Logistics departments and the Quality department throughout the whole lifecycle of a study.
When a drug product is manufactured and quality approved we need to deliver it to a patient, wherever in the world they may be. As a PM in Distribution I coordinate this activity. I manage the generation and approval of distribution instructions for the Almac facilities globally and also for the 60 depots which Almac manage.
I report any potential or actual delays to the Project Leader and work with internal departments to minimize impact on the overall delivery of the study. I delegate tasks to the Project Coordinator, Distribution Coordinator and Depot Coordinator and am responsible for the overall delivery of any distribution aspects of a clinical trial protocol.
Pharmaceuticals are one of the most regulated products to ship so each country has stringent import rules. I work with clients to ensure the correct documentation is in place to obtain approval in each country where the clinical trial is being conducted.