Grez-Doiceau, Walloon Region, Belgium
Responsible for the management of clinical supplies during the execution phase of clinical trials consistent with GMP guidelines Adopt supply strategies in view of changes in trial execution and ensure a seamless transition from study design phase Assess clinical study recruitment rates and ensure supply planning is adopted accordingly Utilize business tools to manage inventories at depots and sites and ensure on-time delivery with minimal overage of clinical supplies Conduct issue resolution activities for supply aspects of clinical studies (e.g., packaging, distribution) Establish and modify trial specific distribution agreements Develop strong internal collaboration with GCO stakeholders to ensure customer satisfaction Interface with Global Trial Managers Manage trial supply budget Develop excellent working relationships with the other groups within Supply
Represent product supply in the Clinical Study Team; Drive the development of tailored clinical trial supply strategies aligned with the relevant clinical trial protocol. Create and maintain complete and accurate clinical supply demand for clinical studies in alignment with protocol requirements, key study parameters and milestones, patient projections, contributes to set‐up of IRT systems. Develop and execute detailed clinical trial supply project plans in close collaboration with stakeholders and in compliance with GxP requirements, local regulations and argenx processes. Drive the development of a study specific pharmacy manual in close collaboration with Clinical Study Team and CMC team. Actively track drug inventory and visualizes active drug consumption versus projected forecast. Contribute to planning and organization of global product manufacturing activities; provides logistics support to the manufacturing team. Responsible for management of external clinical trial supply vendors and distributors; Responsible to consolidate, maintain and track the clinical trial budget.
- Gather clinical and supply assumptions to trigger the study supply optimization - With guidance of Clinical Supply Lead and Optimization experts, define 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 - Provide input to protocol content, country selection and clinical risk databases - Define or select packaging configuration and labeling strategy - Coordinate an optimal IMP distribution strategy to ensure timely delivery to clinical site - Use project management techniques to manage effectively and efficiently the set-up of assigned phase 1-4 trials - Create and maintain project plans, defining and achieving through the lead of cross functional teams the planned milestones regarding clinical supply set-up activities including packaging, labeling, distribution, Interactive Response Technology (IRT) and other supply systems. - Secure optimal transfer of information/knowledge from Clinical Supply Lead, enabling an efficient start of the set-up activities, and guarantee optimal handover of the project to the Clinical Supply Planner, enabling an efficient study conduct. - Drive strong partnership with stakeholders, participating in all required meetings as a liaison for CTS during the study set-up. Educate and influence as needed, to ensure optimal incorporation of CTS input into decisions impacting the IMP supply chain. - Lead study set-up meetings for the internal CTS/QA/GDL stakeholders, collecting input on packaging/labeling design and timelines, and agreeing on trial project plan - Issue or coordinate availability of supply set-up documents - Ensure timely and cost effective supply availability for study start