Responsibilities:
• Designs and implements strategic plans to forecast and supply ancillary materials to global clinical trials using sound supply chain techniques
• Devises and implements inventory management plans that have complex supply chains
• Reviews, interprets and implements supply forecast plans from internal or external source documents and tools.
• Determines the clinical ancillary materials distribution model including depots, customer affiliates and investigator sites.
• Monitors and updates forecasts, tracks usage of clinical ancillary supplies, and monitors inventory levels.
• Maintains documents according to guidelines and relevant procedures
• Executes supply chain inventory management processes in partnership with internal Clinical Ancillary Management team members, packaging and distributing partners.
• Generates requests to customers and or purchasing/vendors to resupply quantities of ancillary materials considering overall project quantities and average lead times for receipt and release of said items.
• Monitors and analyzes project performance to anticipate problems and obstacles, and collaborates with customers, suppliers, distribution and Clinical Ancillary Management team members to prevent and/or resolve issues
• Understands high level import/export requirements for global distribution of clinical ancillary materials and ensures the appropriate distribution personnel are involved to provide guidance and detail import/export requirements, to generate required documentation and to ensure appropriate procedures are in place.
• Plans and manages execution of initial supplies and resupplies for assigned studies
• 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
• Summarizes data, prepares presentations and makes recommendations for actions relative to the ancillary 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
• May lead and/or will participate on teams comprised of customers, suppliers, and/or members of Purchasing, IVRS, Distribution and Packaging to review the clinical study protocol requirements and establish a project plan and timeline. Manages the team and/or the project to deliver against the timeline.
• Participates on or leads Clinical Ancillary Management project teams to ensure Clinical Ancillary Management services are defined and executed.
• Works with both internal and client Project teams to ensure consistent communication of ancillary material supply status. Identifies potential risks, defines and executes risk mitigation plans.
• Obtains written approval from the customer to purchase clinical ancillary supplies when the official purchase order and/or signed proposal have not yet been received.
• Ensures project specific data is configured and maintained in the appropriate Fisher Clinical Services proprietary systems.
• 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 CAM 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
• Verifies final project management, procurement, storage and distribution information for the Finance Department prior to invoices being released Develops and administers training on CAM business processes
• Assists in training and on boarding of new employees
• Participates in sales and marketing activities such as teleconferences, customer visits, audits, estimates and proposals with Sales and other Clinical Ancillary Management personnel.
• Maintains accurate records and files in accordance with Clinical Ancillary Management Policies & Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), Good Clinical Practices (GCPs) and customer requirements.
• Conducts all activities in a compliant, safe and efficient manner.
• Other duties may be assigned to meet business needs.
• Applies Good Manufacturing Principles in all areas of responsibility.
• Demonstrates and promotes the company vision