Description
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
Products: All products + Alliance programs
Major accountabilities:
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
Project and Stakeholder Management
? Uses project management techniques to manage effectively and efficiently the set-up of assigned phase 1-4 trials, or the set-up of new capabilities for CTS
? Creates and maintains project plans, defining and achieving through the lead of crossfunctional teams the planned milestones regarding clinical supply set-up activities including packaging, labeling, distribution, Interactive Response Technology (IRT) and other supply systems.
? Secures optimal transfer of information/knowledge from Clinical Supply Lead, enabling an efficient start of the set-up activities, and guarantees optimal handover of the project to the Clinical Supply Planner, enabling an efficient study conduct.
? Drives strong partnership with stakeholders (CTS functions, Clinical Team, Global Distribution and Logistics (GDL), QA, IRT vendor), participating in all required meetings as a liaison for CTS during the study set-up. Educates and influences as needed, to ensure optimal incorporation of CTS input into decisions impacting the IMP supply chain. Leads 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.
? Ensures Clinical Supply Lead visibility on study supply set-up activities for assigned trials, proactively identifying risks and escalating issues
Study Set-Up
? Contributes to IRT specification development by defining the requirements for IMP/inventory management. Coordinates and/or participates in User Acceptance Testing.
? Issues or coordinates availability of supply set-up documents
? Owns CTS SAP Masterdata linked to assigned studies
? Ensures timely and cost effective supply availability for study start
Specific skills/competencies
Supply Chain Competencies
? Supply Chain Expertise: understands key supply chain processes and can balance cost and service to patients, including advanced understanding of the regulatory and GxPs requirements for IMP's as well as clinical trial distribution particularities
? Augmented Analytics: is able to build queries, summarize data and compute standard KPI's, including financial skills (ability to managed study and compound budget)
? Planning and Orchestring Projects: applies project management techniques in day to day activities