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Our client is a global biopharmaceutical company focusing on creating value for people living with neurology and immunology.
Are you a Clinical Supply Set-Up Manager who's looking for a new mission ?
Feel free to contact me : email@example.com
The Clinical Supply Set-Up Manager is accountable for the project management of the set-up of study supply and new capabilities. 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.
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
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
Gathering & Interpreting information : gathers information and data from relevant sources and systems; contributes to interpretation and analysis
Delivering impactful results: understands and defines how own objectives contribute to value creation, and takes initiatives to exceed them
Thinking holistically : understands the organizational structure and Company Value Chain
Learning through experience : learns from successes and failures, takes accountability for trying out new ideas and appreciates challenge
Working together : manages collaboration with internal and external stakeholders, using influencing skills as well as effective communication, and leveraging diverse thinking
Championing change : handles risk and uncertainty comfortably, adapting self and team to changing circumstances and priorities
Leading others : can organize people into teams, using each person's strengths; is able to motivate and influence a limited range of individuals
wat bieden wij?
We offer an attractive salary with extra-legal advantages :