The Clinical Supply Chain Manager is responsible for planning and managing designated Clinical Supply Chain Management team activities for the Fisher Clinical Services (FCS) Clinical Supply Optimization Services (CSOS) unit. This position will work with FCS clients, packaging sites, depots, Clinical Supply Chain Managers and all FCS internal stakeholders to understand the supply chain requirements and manage clinical trial materials on the study or program level.
Designs and implements strategic plans to forecast and supply study drug to global clinical trials using sound supply chain techniques
Devises and implements inventory management plans that have complex supply chains
Creation, reviews, interprets and implements supply forecast plans from internal or external source documents and tools.
Provides input into user requirement specifications of Interactive Response Technology (IRT) medication management module as needed.
Reviews IRT strategy to ensure it supports the strategic supply plans and ensures that IRT settings are adjusted to optimize the supply chain, combined effort with the Distribution PM
Executes and documents IRT User Acceptance Testing, if required.
Maintains documents according to guidelines and relevant procedures
Executes supply chain inventory management processes in partnership with internal Clinical Supply Optimization Services team members and packaging partners.
Serves as the global project lead on assigned projects, ensuring internal project resources are focused on delivery and client satisfaction
Plans and manages execution of initial supplies and resupplies for assigned studies
Use Simulation as a forecasting tool together with one of the Simulation experts
Presentation of Simulation Outputs to clients
Ensures temperature excursion process is executed as required
Proactively identifies potential supply chain issues, provides analysis and recommends solutions
Performs study close out activities including returned good reconciliation, inventory destruction processing, and file archiving - KPI
Summarizes data, prepares presentations and makes recommendations for action relative to the clinical supply chain and packaging plans
Develops and provides client(s) with reports on actual project spend versus budget
Negotiates effectively with clients regarding study plan without damaging relationships
Provides recommendations on packaging design, distribution (Distribution PM) and blinding strategy with existing clients
Works with both internal and client Project teams to ensure consistent communication of clinical trial material supply status. Identifies potential risks, defines and executes risk mitigation plans.
Takes lead in developing solutions to solve issues with existing clients and projects
Leverages understanding of Fisher resources to propose solutions to clients
Identifies, recommends, and leads process improvement initiatives
Supports communication of best practice through shared learning sessions, contribution to guidelines and SOPs
Identifies new CSOS and other service line opportunities with existing clients and engages Business Development resources accordingly
Establishes and maintains financial forecasts and monthly billing processes for assigned client projects
Recognizes contracted scope of services and connects with the appropriate resources for extensions of service
Develops and administers training on CSOS business processes
Assists in training and on boarding of new employees (buddy concept)
Conducts activities in a safe and efficient manner
Demonstrates and promotes the company vision.
Stays abreast of relevant cGMPs, GCPs, and other regulatory requirements and ensures study management activities are aligned
Other duties may be assigned to meet the needs of the business