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Princeton

    Senior Clinical Trial Manager - Princeton, United States - TK-CHAIN LLC

    TK-CHAIN LLC
    TK-CHAIN LLC Princeton, United States

    3 weeks ago

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    Description

    Job Description

    Job Description
    • 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

    • Manage study vendors where applicable

    • Manage site quality and monitoring deliverables

    • Skills and experience required

    • 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

    • Management of overall project timeline

    • Bid defense experience

    • Strong leadership skills

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