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Position Summary :
Responsible to ensure timely availability of clinical study materials and ancillary supplies to Fisher Clinical Services distribution depots, customer affiliates, and / or investigator sites globally.
This includes collaborating with customers and internal resources to define requirements, develop plans and timelines, and coordinating and executing project activities.
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
Minimum Qualifications :
Bachelor's Degree or equivalent required. Degree in operations management or science related field.
Minimum of 3 years c1inical supply chain experience in logistics or packaging or supply chain management in a related field
Experienced in building and managing forecasts for clinical supply chains
Excellent computer skills, including high proficiency in Microsoft Excel
Strong Project Management Skills
Ability to independently manage priorities and workday in a remote setting
Significant travel (up to 30% may be required. including International travel
Preferred Qualifications :
Understanding of inventory management practices preferred
