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Clinical Trial Supplies Project Leader
* Hold full responsibility for the timely delivery of projects through successful coordination of all tasks associated with packaging, labeling, distribution and drug supply management.
* Propose a suitable kit design for a clinical study, based on considerations such as drug product characteristics, blinding requirements, dosing regime, visit schedule and availability and cost of bulk drug.
* Forecast the quantity of kits required both initially and periodically throughout the clinical trial (or program), based on considerations such as randomization scheme, numbers of patients / clinical sites / depots involved, shelf life of drug and projected / actual enrollment rates.
* Determine the most suitable distribution strategy for the clinical study, based on considerations such as countries involved, randomization scheme, predicted / actual enrollment rates, drug product characteristics and storage capacity at clinical sites / depots.
* Provide information to the Distribution project team to allow distribution pathways, pack out plans and use of depots to be determined and initiated in line with the clinical study start date.
* Work with the IVRS/IWRS (or similar automated system) provider to ensure the correct set up of the clinical study in their system, advising on site and depot supply / resupply parameters.
* Manage activities and customer expectations throughout the life cycle of the project.
* Ensure a project plan is created and frequently updated for each project to reflect the current status of the tasks and to communicate timelines and responsibilities to the customer.
* Liaise internally with other departments and divisions as required, to control the project, resolve problems and escalate issues.
* Hold regular meetings internally with the project team to ensure all team members are fully aware of the status of the project and their responsibilities.
* Perform risk assessments at project start-up and prioritize and problem solve project issues with customers.
* Prioritize, trouble-shoot and problem solve complex clinical supply issues.
* Monitor actual work performed against quotation to ensure project stays within budget.
* Review quality incident reports and technical queries relating to project specific issues.
* High level oversight of critical project documentation.
* Ensure all customer contact, oral and written, is carried out with professionalism in order to develop and maintain good working relationships with all customers.
* Work to a high level of detail & accuracy on all GMP documentation.
* Draft / update departmental SOPs, as required.
* Pharmacy degree with clinical pharmacy experience, desired
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