Senior Specialist - Clinical Supplies Project Manager - Inventory Manager - Hybrid

The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our company Research Laboratories portfolio of clinical trials. GCS is accountable for the planning, sourcing, labelling, packaging and delivery of clinical supplies to clinical sites globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business.

The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our company Research Laboratories portfolio of clinical trials. GCS is accountable for the planning, sourcing, labelling, packaging and delivery of clinical supplies to clinical sites globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business.

This role works within the Planning Execution and Inventory Management Section of the GCS Planning organization. Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates strategic and operational plans associated with the downstream activities of clinical supplies for their assigned studies. The primary function of the IM CSPM is planning the availability of materials and subsequent movement through our depot network and further through to distribution and management of materials to the clinical site.

The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (i.e. clinical development, CMC, supply chain, & human health), and balancing needs of patients & ensuring stable supply of product.

• Participates on the Clinical Trial Team (CTT) and collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical supplies.
• Interacts with key partners in both GCS (Logistics and Trade, Distribution, Operations etc.) as well as other organizations such as Global Clinical Trial Operations (GCTO) headquarter and regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.
• Responsible and accountable for establishing the timelines for clinical supply needs per protocol and ensuring a robust signal for packaging and distribution for Clinical Finished Goods (CFGs)
• Analyzes and anticipates clinical study risks as they relate to clinical supply chain deliverables and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders.
• Responsible and accountable for utilizing key tools/systems such as IRT & Microsoft Power Apps, SWMS, Veeva, MEDS, My Learning, and other Microsoft Applications in the management of clinical supplies for assigned studies.
• Works directly in the SAP system to ensure a robust and consolidated forecast for CFGs is maintained.
• Report clinical supply chain incidents to support the gathering of metrics in GCS to describe business health. Participate in root causing to identify areas for operational improvement.
• Participates in initiation and timely processing of change controls through collaboration with GCS Planning and other cross functional stakeholders and in accordance with established GCS planning SOPs/BPs and QMS Topic 3.4 Change Control Procedures and Work Instructions.
• Participates in authoring and timely processing of deviation records as well as supports deviation investigations as required.
• Participates in critical non-pipeline and compliance activities in support of GCS Planning (e.g.,…