Karen Ragnauth

Director Clinical Quality Oversight & Risk Management at Shionogi

Karen Ragnauth has a diverse and extensive work experience. Their most recent position is as a Senior Manager in Risk Management Coordination at Shionogi Inc. starting from 2022. Before that, they worked at Acadia Pharmaceuticals Inc. as a Senior Manager in R&D Quality and Risk Management and previously as a Quality and Risk Management Manager. In this role, they supported all Quality and Risk Management activities, provided quality input, and generated trial risk assessments. Karen also contributed to developing effective quality control and risk management procedures.

Karen also served as the Vice President of Operations at Cronos Clinical Consulting Services, Inc. from 2012 to 2019, where they played a key role in growing the organization and developing first-to-market solutions for clinical efficacy outcome risk-based data monitoring platforms. Karen also held the position of Director of Operations at Cronos Clinical Consulting Services, Inc. from 2009 to 2012.

Prior to that, Karen worked as a Project Manager at MedAvante from 2007 to 2009, where they managed independent remote ratings for CNS assessments in clinical trials and contributed to the development of methodology for capturing central clinical outcome/efficacy assessments. Karen also managed internal research and information technology projects, including the launch of paperless data capture.

Karen's work experience also includes the role of Project Manager at Bioclinica from 2006 to 2007, where they managed a core lab image facility and supported clinical operations for active protocols in accordance with industry regulations. Karen specialized in global oncology trials.

Before that, they worked at New England Research Institutes (NERI) as a Senior Clinical Research Associate. In this role, they were involved in various studies, including Autism Treatment Network, the Thalassemia Clinical Research Network, and the Children's Amalgam Trial. Karen also served as a Research Administrative Assistant at NERI.

Earlier in their career, Karen worked as a Respite Care Provider at Toward Independent Living and Learning, Inc., where they provided recreational activities to children with special needs, focusing on Autism and developmental disabilities.

Overall, Karen Ragnauth has demonstrated expertise in risk management coordination, quality control, project management, and clinical research. Their background includes working in the pharmaceutical industry, clinical consulting services, and research institutes. Karen has consistently shown a commitment to developing effective quality control processes and managing complex projects in various healthcare settings.

Karen Ragnauth holds a Bachelor's of Science degree in Psychology from Northeastern University. No specific start or end year information is available for their education at this institution.

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Timeline

  • Director Clinical Quality Oversight & Risk Management

    July 1, 2023 - present

  • Sr Manager Risk Managent Coordination

    January, 2022

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