• CTMS QC Program Manager

    Job ID
    13052
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Clinical Research Support Services
  • Overview

    Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.


    The CTMS Program Office is a tri-institutional office housed within the Fred Hutch Research Administration department providing implementation and operational support services for the OnCore Clinical Trial Management System (CTMS) that is jointly managed by the Fred Hutch, the University of Washington and the SCCA. 

     

    The CTMS QC Program Manager is a hands-on leadership role within the CTMS Program Office team that will support the lifecycle management of CTMS Data QC, including defining the QC plan across the CTMS Office and Parallel Offices, defining SOPs and QC reports, QC execution, study team outreach management, parallel office coordination, and metrics management. The scope of the QC Program will expand as new functionality is implemented and use of the CTMS grows. 

     

    The CTMS QC Program Manager should have critical thinking skills for complex problem solving and high-end data analysis skills as it relates to clinical trial workflow data.  The manager should be a keen analyst and a thoughtful communicator carefully achieving the overall goals of data stewardship through nurturing of partnerships with study teams and research administration leadership. They should bring strategic and tactical abilities to identify key operational process improvements through the data and trends that are brought to light via the QC process. This role is outward facing and requires exceptional customer service, communication and relationship building skills. 

    Responsibilities

    • Managing tri-institutional CTMS QC functions, including defining and maintaining a comprehensive QC matrix that outlines the What, Who and When for each data topic that will be QC’d  
    • Managing a QC team of 1-2 direct reports 
    • Defining the operationalization plan for all QC topics that are owned by the CTMS Program office including development of SOPs and working practice guidelines 
    • Defining QC metrics and developing a QC dashboard for stakeholder and leadership review 
    • Defining and overseeing the development of the CTMS reports that will be required to support the QC process 
    • Implementing QC efforts, outreaching to study teams, parallel offices, administrative leadership and investigators as appropriate 
    • Identifying operational process improvements that come to light through the QC process and partnering with the CTMS Program Office Leadership team to support implementation of improvements   
    • Communicating QC program-related messages and updates to a diverse set of stakeholders ranging from study team staff to administrative staff, leadership and faculty 
    • Coaching, mentoring for staff and peers within the CTMS team and partner offices 

    Qualifications

    • Bachelor’s Degree 
    • Minimum 3-4 years’ experience in Clinical Research Operations or health care operations with a focus on data management 
    • Experience with CTMS systems; OnCore experience is desired 
    • Demonstrated experience in data analysis and trends identification  
    • High level of reliability and flexibility with the ability to handle ambiguity and incomplete information, multiple moving parts and high-volume, complex issues while exercising thoughtfulness and independent sound judgement  
    • Effective time management skills; ability to handle time sensitive deadlines and quickly pivot when unexpected events or changes present themselves 
    • Excellent communication (written and oral), customer service, collaboration, problem solving and interpersonal skills with the ability to connect, and build strong working relationships 
    • Superior organizational skills and attention to detail mindset 
    • Proven ability to work effectively with a diverse group of stakeholders, including the operations team, cross functional team members, study teams, parallel offices, leadership, and personnel at various levels in the organization 

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