The Clinical Safety Manager plays a pivotal role in the Clinical Operations function by serving as an expert to the Center for Cellular Immunotherapy (CCI) organization. The Clinical Safety Manager facilitates continuous improvement of CCI’s proactive Serious Adverse Events (SAEs), Adverse Events (AEs), Safety reporting and Safety Management processes and systems, including development of standards, processes, and training for clinical safety oversight for all CCI clinical trials. The Manager monitors adherence to regulatory requirements (ICH, FDA, NIH, NCI, etc.) and GCP guidelines, leads efforts to identify potential compliance and quality risks to CCI safety management in clinical trials, and develops mitigation strategies with the assistance of clinical operations and QA personnel.
Responsibilities: * Develop Clinical Safety SOPs and Safety process Guide to Daily Operations * Partner and interface with the Office of Clinical Research (OCR) on safety activities related to the CCI clinical studies. * Collaborate with the CCI Medical Director, Study Medical Directors, Study Project Managers, Clinical Sites and Scientists in CCI to perform clinical safety to ensure high standards of clinical trial conduct and analysis * Develop Safety Reports, Quarterly Safety Reviews, Investigator Notification, CCIIMV AE analysis reports and safety reports for IND/RAC Annual Reports and DSMB meetings. * Provide AE and SAE guidance and SAE Form training
Internal Number: 42067
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