The OpportunityThe Clinical Trial Supply (CTS) Senior Study Manager manages the end to end supply chain for assigned clinical studies throughout the multi year study lifecycle. The CTS Senior Study Manager independently leads clinical studies to ensure compliant, supply of study medication and ancillary materials for our patients. Responsibilities include determining kit design and blinding, forecasting demand of investigational product and ancillary supplies, establishing, and managing the depot network and distribution to clinical sites, and ensuring final return and destruction. The CTS Senior Study Manager also leads process improvement projects for the clinical supply chain and may have direct reports.The RoleGive input to and oversee the implementation of multi year clinical supply strategies and plans for assigned simple to complex clinical studies.Gather and documents requirements for clinical supplies based on protocol attributes and clinical assumptions. Influence the protocol design for clinical supply reliability and efficiency.Lead demand forecasting for study(ies); use simulation and optimization tools capabilities to improve clinical supply plans and minimize the effect of inherent uncertainties; adjust plans monthly based on actual use and changes to clinical and supply assumptions; confirm supply plans.Specifies ancillaries supplies with input from Clinical Development Operations, Clinical Science and Product Development; plans demand for centrally supplied materials.Present IMP related CTS topics in Study Execution Teams, Clinical Development Teams and Product Development Expert Team/Chemistry, Manufacturing, and Controls Team.Determine labeling and clinical kit design based on protocol and countries'' needs; implement pooling concepts in the study.Monitor global network of regional depots and global depots to distribute drug supplies and ancillary supplies to countries and sites in assigned clinical studies.Coordinate compliant importation and supply of drug supplies and ancillary supplies into regional depots and global depots. Manage the inventory levels and product expiry.Ensure on time delivery of drug supplies and ancillary supplies from depots to clinical sites and patients.Develop clinical trial supply documents and training to support study execution for clinical sites and patients (e.g. Investigational Medicinal Product (IMP) Manuals, product preparation and administration videos).Train external partners (i.e., clinical monitors, clinical site personnel) and internal global clinical study teams regarding IMP handling.Files proper documentation throughout the study and after study closure.Use Interactive Response Technology (IRT) systems to ensure reliable and efficient clinical supply to depots and sites.Co develops IRT specifications for drug supply management, participates in user acceptance testing and monitors inventory levels and IRT resupply settings. Adjust system settings based on study progress and changes to