CTMS QC Program Manager

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 Hutchs 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 nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The CTMS Program Officeis atri-institutionalofficehoused within theFred Hutch Research Administration departmentprovidingimplementation and operationalsupportservicesfortheOnCoreClinical 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.

• Managingtri-institutionalCTMSQCfunctions,includingdefining and maintaining a comprehensive QC matrixthat outlines the What, Who and When for each data topic that will be QCd
• Managinga QC team of1-2 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 tosupport 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
• CommunicatingQC program-related messagesand updates to a diverse set of stakeholders ranging from study team staff to administrative staff, leadership and faculty
• Coaching, mentoring forstaff and peers within theCTMS team and partner offices

• Bachelors Degree
• Minimum3-4years experienceinClinical Research Operationsorhealthcare operationswith a focus on data management
• Experiencewith CTMS systems; OnCore experience is desired
• Demonstrated experience indataanalysis andtrends identification
• High level of reliabilityandflexibilitywith theability to handleambiguityand incompleteinformation, multiple moving parts and high-volume, complexissueswhileexercising thoughtfulness and independent sound judgement
• Effective time managementskills; ability to handle time sensitivedeadlines and quickly pivot whenunexpected events or changes present themselves
• Excellentcommunication (written and oral), customer service,collaboration, problem solvingandinterpersonal skills with the ability toconnect, andbuildstrong workingrelationships
• Superior organizational skillsand attention to detailmindset
• Proven ability to work effectivelywitha diversegroup ofstakeholders,includingthe operations team, cross functional team members,study teams, parallel offices, leadership, and personnel at various levels in theorganization

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.