Senior Manager, Clinical Complaince

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Irfa******

  • United States 
  • Last Update: 23.08.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
Plymouth Meeting, PA, US
Country
United States

Description


Company Profile

Inovio is a late-stage biotechnology company focused on the discovery, development, and commercialization of DNA immunotherapies that transform the treatment of cancer and infectious diseases. Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. Inovio has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include MedImmune, Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar Institute, University of Pennsylvania, the Parker Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and Laval University. For more information, visit www.inovio.com.

Job Summary

The Senior Manager, Clinical Compliance is responsible for overseeing/managing compliance activities related to Clinical Trial conduct. This position leads the assessment and investigation of reported serious noncompliance issues (SINC) cases and serves as CAPA Coordinator for these issues, as applicable. This role serves as a liaison between Clinical Compliance and Clinical Operations, Quality Assurance, and Regulatory Operations, and as Clinical Compliance Lead on selected program/protocol teams. The Senior Manager also mentors Clinical Teams in the development of appropriate audit and/or inspection responses and corresponding corrective

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