Montash are currently looking for a Clinical Supply chain manager for a role in Brussels
Nature and Scope:
The Clinical Supply Set-Up Manager is accountable for the project management of the set-up of study supply and new capabilities at CTS
He/she plans, coordinates and communicates clinical supply activities for all applicable clinical trials during their set-up phase, aiming to achieve optimal quality, time and budget.
He/she implements the strategy defined in collaboration with stakeholders and provides visibility on clinical supply chain during trial set-up.
Scope: All clinical trials (phase 1-4) + Compassionate Use Programs (EAP/NPP/MAP) with CTS involvement + Investigator Initiated Trials/Studies (IIT/ISS) with CTS involvement
Study Supply Strategy definition and implementation
Gathers and challenges clinical and supply assumptions to trigger the study supply optimization
With guidance of Clinical Supply Lead and Optimization experts, defines an optimal IMP supply strategy to ensure adequate and sufficient forecasting of IMP. Establish production plan, distribution plan and IRT settings for the start of the study
Provides input to protocol content, country selection and clinical risk databases
Defines or selects packaging configuration and labeling strategy
Coordinates an optimal IMP distribution strategy to ensure timely delivery to clinical sites