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    Clinical Trails Manager - Cincinnati, United States - Katalyst Healthcares & Life Sciences

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    Full time
    Description
    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


    Requirements:
    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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