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Lalande-de-Pomerol

    Manager, Clinical Research - Miami, United States - The University of Miami

    The University of Miami
    The University of Miami Miami, United States

    2 weeks ago

    Default job background
    Description

    Current Employees:

    If you are currently working as a Staff, Faculty, or Temporary employee at the University of Miami, please log in to Workday to use the internal application process.

    To find out how to apply for a faculty or staff position through the Career worklet, review this tip sheet.

    Join the dynamic team at the Department of Pathology and Laboratory Medicine as a full-time Manager of Clinical Research based in Miami, FL.

    The Manager of Clinical Research plays a crucial role in overseeing the development of clinical trials and research programs supporting the university's mission.

    This position entails making regulatory decisions, coordinating with study managers to ensure study protocols' accuracy, and collaborating with team members for successful data collection.

    CORE JOB FUNCTIONSCollaborate with investigators and study teams to meet targets and milestones, handle timely submission to IRBs, sponsors, and master agreements, manage Regulatory Affairs submissions related to University-held INDs and IDEs, and coordinate with the Research Program Director for study compliance.

    Organize project plans, assign tasks to the team, monitor daily workflows, identify resource requirements, conduct quality checks, and address any functional or timeline issues promptly.

    Build and maintain relationships with investigators, manage IND and IDE documentation, handle proposal tracking, facilitate project-related meetings, and ensure project documentation complies with standards and regulations.

    Identify opportunities for process enhancement, collaborate with project teams for effective submission logistics, maintain records of INDs and IDEs, and prepare annual reports on clinical trials and research.

    Be a consultant for INDs and IDEs, develop and enforce internal and University-wide policies to ensure FDA compliance and best practices in Clinical Research, establish and review internal controls, and provide training on controls and policies to employees.

    Be prepared to take on additional responsibilities beyond the listed duties.

    CORE QUALIFICATIONSEducation:

    Master's degree in a relevant fieldExperience:
    A minimum of 5 years of related experienceA combination of education, experience, and certification will be considered.

    DEPARTMENT ADDENDUMDepartment Specific FunctionsThe Department of Pathology and Laboratory Medicine (DPLM) is a thriving multi-disciplinary department within the University of Miami Miller School of Medicine.


    It comprises four distinct divisions:
    Anatomic Pathology, Hematopathology, Comparative Pathology, and Laboratory Medicine. DPLM Research covers basic, translational, and clinical research.

    The role of Manager of Clinical Research involves overseeing all pathology-related clinical research study requests, managing research coordinators, developing research guidelines and SOPs for specimen management, participating in relevant committees, and providing pathology expertise for research studies.


    Review biospecimen-related research studies submitted to the IRB, enforce guidelines across UM departments and centers, and keep abreast of research guidelines and practices.


    Knowledge, Skills, and Attitudes:
    Understanding of business and management principles.
    Ability to manage department operations effectively, set goals supporting the strategic plan, delegate work, supervise, lead, and motivate team members to success.
    Be part of a dedicated team that provides leading-edge patient care, supported by groundbreaking research and education at the Miller School of Medicine, part of UHealth-University of Miami Health System.

    Don't miss the chance to work at an academic medical center that serves diverse regions and offers a wide range of specialties and sub-specialties to over a million patients annually, with a global reputation for excellence in teaching, research, and care.

    Join us in upholding the highest standards of patient safety, including mandatory annual influenza vaccinations for employees in patient care areas or clinical settings during flu season.

    Discover a fulfilling career opportunity at the University of Miami, an Equal Opportunity Employer.


    Job Status:

    Full timeEmployee Type:
    Staff

    Pay Grade:
    A13
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