• Senior Manager, Clinical Data Management

    Job ID
    11325
    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 and largest 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 Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is seeking a Senior Manager of Clinical Data Management (CDM) to provide overall leadership and management of the clinical data management team and direct supervision of CDM managers, the manager of Clinical Safety and Coding and other CDM staff as needed. The incumbent will be responsible for ensuring that the CDM group is operating effectively and that it meets the requirements of the research protocols in a regulatory compliant manner.   

    Responsibilities

    Leadership

    • Provide strategic, organizational, and operational management and guidance to the Clinical Data Management group.
    • Collaborate with the other SCHARP senior managers to create and implement overall organizational vision and strategic direction.
    • Develop strong working relationships and maintain effective communication with clients, partners and colleagues.
    • Optimize interdisciplinary understanding and teamwork across functions to drive effective and efficient Clinical Data Management practices.
    • Foster and promote the long-term development of the Clinical Data Management team, work closely with the SCHARP Director, senior management team, and the CDM managers to define ways in which the team contributes to the advancement of SCHARP and to improve the operational effectiveness of the group.

     

    Management

    • Supervise Clinical Data Management and Safety and Coding managers, and other CDM staff as needed.
    • Develop and maintain staff morale, engagement, and professional development.
    • Monitor group project and protocol workflows, capacity, priorities, timelines, deliverables, documentation and resources and communicate issues regarding conflicts and/or resource limitations.
    • Represent the interests of the CDM as a member of SCHARP Senior Management Team.
    • Provide technical and functional oversight of the day-to-day work and work products of clinical data management staff, as needed, including clinical data collection, processing, and quality control procedures, timelines and documentation.
    • Provide training, direction and performance management for individual employees; manage workloads and priorities, support professional development, work with Fred Hutch Human Resources staff to facilitate recruiting efforts and staffing changes.
    • Act as clinical data management liaison/lead with research partners, sponsors, and 3rd party clinical data management vendors.
    • Review and approve the launch and close of studies/projects ensuring that all project work has been fully completed, documented and stored.
    • Escalate project and departmental issues to SCHARP Director as needed

     

    Change Management and Quality Assurance

    • Lead departmental efforts to standardize work practices and develop standard operating procedures in conformance with GCP, GCDMP, and ICH guidelines, and that meet regulatory submission requirements, and CDISC standards.
    • Identify and implement process improvements of SCHARP procedures and practices by chairing and/or participating on teams, committees and working groups.
    • Oversee and ensure quality assurance of CDM in coordination with the Quality Management section.
    • Develop and maintain standardized tools, procedures and training materials.
    • In partnership with SCHARP’s Senior Management Team, Business Support Services team and the Project Management Steering Committee prioritize and manage the implementation of SCHARP continuous quality improvement, regulatory compliance, operational effectiveness, and technical infrastructure improvement CDM projects.
    • Facilitate adoption of new and forward-thinking practices technologies and tools that improve the efficiency, effectiveness or the regulatory compliance of the group.
    • Evaluate and identify efficiencies and process improvements including leading infrastructure and technological upgrades as needed to improve CDM intake, workflow, documentation, tracking, and project and protocol management

    Qualifications

    Minimum:

    • Bachelor’s degree in related field and a minimum of eight years of experience in clinical research, data management or related field, of which 4 years is in a leadership or management role, or equivalent combined years of education and experience.
    • Demonstrated leadership, management, supervisory, and collaboration skills across functions to drive effective and efficient Clinical Data Management practices.
    • Excellent project management and organizational leadership and change management experience.
    • Experience in the development and use of commercial clinical data management. Systems and/or EDC products.
    • Advanced knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements.

     

    Preferred:

    • Graduate Degree in life sciences or related disciplines
    • 10+ years of experience in CDM, with at least 5 years’ management experience in a pharmaceutical, CRO, biotech or life sciences research organizations.
    • Working knowledge of CDISC
    • Advanced knowledge of clinical research business and regulatory requirements

    Our Commitment to Diversity

    We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, 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 escmail@fredhutch.org or by calling 206-667-4700.

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