University of Pennsylvania

Philadelphia, Pennsylvania

Duties: 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.

Qualifications: Bachelors degree and 5 to 7 years of experience in Clinical Safety Management, Clinical Development and Operations, and/or Clinical Quality Assurance or an equivalent combination of education and experience required.
* RN preferred
* Experience in SOP and process design related to clinical safety management
* Extensive knowledge of FDA / global clinical trial regulations and ICH GCP Guidelines
* Understanding of the clinical development process and clinical safety documentation requirements
* Proactive approach to GCP clinical safety compliance
* Attention to detail, excellent communication skills and be able to work within a team under challenging and sometimes stressful conditions
* Exceptional knowledge of commonly-used clinical safety concepts, practices, and procedures within GCP area
* Ability to work independently with minimal direction.

Reference Number: 40-30037

Salary Grade: 028

Employment Type: Exempt

Org: CI-Center for Cellular Immunotherapy

Special Requirements:

Job Family: I-Technical/Professional Research

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