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    Director Clinical Project Management - New York, United States - iPharm

    iPharm
    iPharm New York, United States

    2 days ago

    Default job background
    Full time
    Description
    Summary of 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
    • Manage study vendors where applicable
    • Manage site quality and monitoring deliverables
    Education, Qualifications, and Experience
    • 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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