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