This position is responsible for the management of Clinical Trials Material (CTM) in support of Global R&D Clinical Trials and other supportive research or development needs. Responsible for determining CTM requirements through protocol review, ensuring label compliance with applicable regulations, establishing optimal packaging & distribution strategies, tracking and reconciling drug supplies and monitoring product re-test dates. Maintains databases appropriate for CTM management operations and provides timely documentation and reports.
The position will interface with other internal departments and contract research organizations to coordinate execution of these activities. Additional responsibilities may include maintaining departmental reports and files, updating SOPs, and other special projects.
M.S./B.S. or equivalent in pharmacy or a related discipline coupled with at least 5 years of experience in managing clinical trials material. Good understanding of the CTM forecasting, distribution and reconciliation process. Excellent communication, organizational, problem solving and interpersonal skills with the ability to work in a global development and manufacturing environment. Demonstrated ability to multitask in high pressure, changing conditions and to work as part of a larger team.
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