Contract - Clinical Supply Chain Study Manager

CONTRACT - CLINICAL SUPPLY CHAIN STUDY MANAGER

Position Summary:

This position will manage activities related to planning and execution necessary to ensure timely and continuous drug supply to global clinical studies. Serves as a key interface between the Technical Operations and Development/Clinical Operations teams in matters of product supply.

Essential Duties and Responsibilities:

• Demand planning and forecasting - able to translate clinical study synopsis/protocols into actionable drug forecasts
• Systems - Develop any required Interactive Response Technology (IRT) supply strategies, review and provide input on User Requirement Specifications (URS) and participate on User Acceptance Tests (UAT) as required
• Supply strategies - Collaborate with other Supply Chain team members to develop effective packaging and supply strategies maximizing available inventory by location and shelf life while minimizing waste and potential obsolescence
• Distribution and Logistics - set up, manage and monitor global distribution networks based on study requirements. Collaborate with other Supply Chain team members to ensure required Import/Export documentation is available
• Inventory Management - manage global depot inventory supporting clinical studies
• Participate in Clinical Study Execution Team (SET) meetings as Supply Chain Subject Matter Expert
• Effective cross-functional collaborator and communicator. Interface with GBT's CMC team, Regulatory Affairs, Quality Assurance, Clinical Operations groups, and others as required to meet project deliverables
• Financial acumen - manage budgets, negotiate vendor contracts as required
• Vendor management - effective vendor oversight ensuring timelines are met. Manage external vendor relationships as required
• Procedures - develop and establish Standard Operating Procedures (SOP's) as required
• Other activities as required could include assisting with global shipment and logistics coordination of Drug Substance, Drug Product and other compounds

Qualifications:

• BS/BA or MBA degree
• Working knowledge of cGXP's, familiar with US, EU regulations applicable to investigational drugs and drug development process
• Good organizational and communication skills, effective project and time management skills, and able to meet tight timelines. Excellent interpersonal skills
• Customer Service oriented, collaborative and self-starter
• Proficient in Microsoft Outlook, Word & Excel. Excel modeling capabilities a plus