p>Qualifications: Bachelor's Degree or higher in health or life sciences, preferred Minimum of 4 years' experience in the pharmaceutical/biotechnology industry performing global clinical trial supply logistics/management, including supply chain and labeling Experience interpreting clinical trial protocols and developing well-planned, accurately forecasted clinical supply forecasts Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives Proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook, etc.), Electronic Data Capture systems Demonstrated leadership capabilities, effective organizational skills, and excellent verbal and written communication Ability to work in a fast-paced, complex environment amongst internal and external partners.
Establish and document supply chain for each project according to required scope Manage supply planning/forecasting to ensure alignment with study activity and timelines Assist Legal with obtaining procurement and/or supply agreements for any required commercially sourced products Monitor inventory levels at sites and depots through the life of a trial taking preventative actions to avoid supply issues Manage, reconcile, maintain and report an accurate account of IP inventory on-hand, consumption, movements, lot and expiry tracking Collaborate with study team and vendors to assure proper distribution of IP to study sites Develop excellent working relationships with QA / RA for timely review and approval of batch records for packaging and labeling of IP.