• Manager - Clinical Research Systems

    Job ID
    F1073
    Department
    Information Services
    Category
    Clinical Research
    Job Location
    US-TN-Memphis
  • Overview

    St. Jude Children’s Research Hospital is a world-renowned institution that is recognized as one of the best places to work in the nation. As a premier center for research and treatment of childhood catastrophic diseases, we employ a diverse team of scientific and healthcare professionals dedicated to the promise of hope. With our critical mission, St. Jude is revolutionizing the way our clinicians use information systems and advanced technology to deliver lifesaving patient care.

     

    The Manager Clinical Research Systems will assist with the coordination and development of complex clinical research information system programs, projects and trials, implementation of new clinical trials management applications, integration with 3rd party applications, clinical research system upgrades, implementation of associated ancillary applications, and oversight and evaluation of resource utilization. Supervises a team of Research Informatics Developers and Analysts, that develop EDC databases matched with specific IRB approved clinical research protocols. Works collaboratively with system users, technical resources, the operational analytics team and ensures that necessary data reports are provided to users. Assists with the integration of systems across departmental boundaries to ensure that solutions are consistent with the broader goals and objectives of the overall institution. Provides oversight of training program development, user documentation and continuous improvement initiatives. 

    Responsibilities

    1. Manages the development and/or maintenance of study-specific databases in the Clinical Research System and/or within legacy systems.

    • Works with users to develop databases for IRB-approved clinical research protocols and institutionally approved non-research databases
    • Maintains open communication with users, including Investigators, Research Nurses, CRAs, Data Managers, Clinical Trials Operations Monitors, Biostatisticians, and others to ensure responsiveness to user needs.
    • Assist in the development and oversight of quality assurance measures including thorough, detailed test plans and reconciliation of data transfers between disparate systems
    • Works closely with other functional groups to facilitate development of new functionality, correcting deficiencies, implement enhancements, compliance with standards, i.e. CDISC, report development and generation and quality assurance initiatives

    2. Manages the overall operations and ongoing development for assigned clinical research system applications.

    • Assist in the development of specifications to be customer approved, in line with current standards, and utilized in the development, implementation and deployment of system solutions
    • Continually evaluates system performance and system functionality and document instances for review by the Clinical Research Informatics Management team
    • Provides support and direction to assigned staff members, vendors and/or consultants
    • Manage and collaborate with team members to ensure issue escalation, priority setting, system specifications, solutions review and knowledge transfer
    • Actively seeks to identify opportunities for new and more efficient ways of conducting busines

    3. Directly supervises the assignments, performance, and productivity of staff

    • Oversee workflow of staff and delegates work to individuals
    • Interviews, selects, and trains employees to maintain an effective and efficient staff.
    • Completes performance reviews, provides ongoing feedback regarding performance and productivity, and recommends salary adjustments, as appropriate

    4. Maintains an awareness and understanding of technological advances, vendor product offerings an issues.

    5. Maintains working knowledge of all Clinical Research Informatics management methodologies and ensures staff development.

    6. Positively influences team member’s performance through orientation, monitoring, feedback, education and counseling.

    7. Performs other related duties as assigned or directed in order to meet the goals and objectives of the department.

    Minimum Education

    Bachelor’s Degree in Health Administration, Health Care, Information Systems, Computer Science or related field is required

    Master’s Degree in Health Administration, Information Systems, Computer Science or related field is a plus

    Minimum Experience

    • Minimum seven (7) years of informatics experience in a clinical research environment that includes two (2) years of supervisory and project management
    • Experience with complex, integrated clinical research systems required
    • Clinical Research Systems’ focused informatics experience including knowledge of 21 CFR Part 11 Compliance, Clinical Trials Management Systems, reporting and multiple system integrations is preferred
    • Previous experience with clinical trials and research information systems is preferred

    EEO Statement

    St. Jude is an Equal Opportunity Employer

    No Search Firms:

    St. Jude Children's Research Hospital does not accept unsolicited assistance from search firms for employment opportunities. Please do not call or email. All resumes submitted by search firms to any employee or other representative at St. Jude via email, the internet or in any form and/or method without a valid written search agreement in place and approved by HR will result in no fee being paid in the event the candidate is hired by St. Jude.

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