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Clinical Studies Specialist
 Spectraforce Technologies | |
 United States, Illinois, North Chicago | |
 Sep 20, 2024 | |
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Job Title: Clinical Studies Specialist
Duration: 12 months Location: North Chicago, IL 60064 Major Responsibilities: o Planning, scheduling, coordination and execution, in support of clinical supply project manager to ensure the timely availability of investigational drug supplies and related services to clinical sites and depots. o Translates stability and packaging requests into an executed packaging design. o Identifies, develops, communicates and tracks task completion dates , activities, logistics, and milestones in support of clinical supply project manager to ensure the timely availability of investigational drug supplies o Responsible for creating appropriate protocol specific manufacturing and packaging work orders in concert with the clinical supply project manager. o Responsible to complete tasks identified for the team. o Responsible for inventory management system set up activities (i.e. Material masters, manufacturing requests, etc) to support clinical packaging operations * Critical Success Factors o A basic understanding of clinical development and global supply chain requirements. o Competent in the application of standard business requirements (for example SOPs, Global Regulations). o Understanding the importance of compliance in a regulated environment and be capable of applying this knowledge to daily work. o Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional and effective manner. o Ability to work effectively and professionally with those in the dept as well as QA, Analytical and any area interface. o Ability to manage and prioritize multiple tasks. o Basic Project Management skills. o Good communication skills (both written and oral). **Also interested in expanding to resumes with materials management systems experience, ideally in pharma context. Education Requirement: Bachelor's Degree required preferably in physical science, math, engineering, pharmacy or data science. Experience: 2-4 years total experience in the Pharmaceutical Industry. | |