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    Clinical Trials Manager - Cincinnati, United States - INTELLECTT INC

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    Intellectt Inc background
    Description

    Position :
    Clinical Trials Manager

    Location :
    Cincinnati OH 45227


    Job Type :
    Full-Time


    Work Type :
    Onsite/Hybrid

    Job Summary


    The Client is the leading CRO for Biotech companies and is continuing to add established Project Managers to join our Clinical Trial Management Group in Cincinnati, OH.

    Our therapeutic areas of focus include Oncology/Hematology, Cardiovascular/Metabolic, Infectious Disease, Neuroscience, and more.

    Responsibilities

    Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations
    Serve as primary Sponsor contact for operational project-specific issues and study deliverables
    Maintain in depth knowledge of protocol, therapeutic area, and indication
    Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided
    Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable
    Develop operational project plans
    Manage risk assessment and execution
    Responsible for management of study vendor
    Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables

    Qualifications

    Bachelor's degree in a health-related field; Advanced degree in a health-related field preferred

    Experience in Phases 1-4; Phases 2-3 preferred

    5+ years as a project/clinical trial manager within a CRO; required for home-based

    Management of overall project timeline

    Strong leadership skills
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