Clinical Project Manager
 Spectraforce Technologies | |
 United States, Illinois, North Chicago | |
 Oct 29, 2024 | |
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Job Title :Clinical Project Manager Location: North Chicago IL 60064 Length of assignment: 1 year to start * Education Requirement: Bachelor's Degree required preferably in physical/biological science, math, engineering or pharmacy. * Experience: 2+ years total experience in the Pharmaceutical Industry. Preferably experience in one of the following areas: * Drug discovery (eg, Process Chemistry, Analytical Chemistry) * Drug development (eg, Formulation) * Clinical operations (eg, Clinical Project Management) * Supply chain (eg, Clinical Supplies Project Management) * Quality Assurance Major Responsibilities: * Responsible for the project management of key Clinical Supply Chain activities at the protocol level for and Phase I - IV clinical trials * Includes forecasting, planning, scheduling, coordination and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots. * Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources. * Translates clinical study design into packaging design. Authors the study medication and labeling section of the clinical protocol. * Develops protocol specific labeling compliant with applicable global regulations. * Identifies, develops, communicates and tracks project timelines, activities, logistics, and milestones. * Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning. Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies and commodities, including overages. * Critical Success Factors * Understanding of clinical development and global supply chain requirements. * Competent in the application of standard business requirements (for example SOPs, Global Regulations). * Understanding the importance of compliance in a regulated environment and be capable of applying this knowledge to daily work. * Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional and effective manner. * Ability to work effectively and professionally with those in the dept as well as Clinical, QA, Analytical and any area interface. * Ability to manage and prioritize multiple tasks. * Project Management skills. * Good communication skills (both written and oral). | |