Director, Data Services and Governance

Company: Fred Hutchinson Cancer Research Center
Location: Seattle
Posted on: May 14, 2022

Job Description:

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Licensed Practical Nurse (LPN) - Float Pool *$5,000.00 Sign-on Bonus* in Seattle, WA Featured Employers Company: Fred Hutchinson Cancer Research Center
Location: Seattle, WA
Employment Type: Full Time
Date Posted: 04/14/2022
Expire Date: 05/14/2022
Job Categories:Healthcare, Practitioner and Technician, Human Resources, Information Technology, Installation, Maintenance, and Repair, Law Enforcement, and Security, Science, Executive Management, Research & Development, Medical, Nonprofit and Volunteer Services, Energy / Utilities Job Description OverviewCures 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, HIVAIDS 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 HIVAIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center primarily focused on HIV prevention research. SCHARP has an annual budget of over $50 million, more than 190 employees, and is currently managing over 40 active phase I - III clinical trials in over 200 clinical sites around the world. SCHARP is seeking a Director of the Data Services and Governance team. The Director of Data Services and Governance is responsible for leading and delivering a commitment to improving the integrity, value, and usability of SCHARP's critical data assets through better governance, security, and enterprise architecture of its data. The Data Services and Governance Director provides overall leadership and management of the data services group and is a member of SCHARP's senior management team. In this leadership role, the Data Services and Governance Director partners with the SCHARP Executive Director, the Senior Management Team, and other managers, subject matter experts, and stakeholders to develop department-wide strategy, vision, mission, infrastructure, policies, and standards.Responsibilities

• Provide strategic direction for governance of SCHARP's critical data assets to support both business and technical direction and operational management of the Data Services Unit.
• Coordinate the production of a Data Governance Roadmap and steer its implementation.
• Oversee ongoing adherence and compliance and security of SCHARP's critical data assets.
• Collaborate with the other SCHARP Directors to create and implement overall organizational vision and strategic direction.
• Provide technical vision and guidance on the development of infrastructure needed to support and maintain data governance for regulated Phase I/II/III clinical trials and the various R&D/pre-clinical studies. -
• Oversee the development and maintenance of data security architecture standards, processes, and guidelines.
• Serve as the data governance subject matter expert and liaison with research partners, sponsors funders, regulators, and 3rd party vendors.
• Lead departmental efforts to standardize work practices and develop standard operating procedures in conformance with GCP, GCDMP, GDRP, HIPAA and ICH guidelines, and that meets regulatory submission requirements, and CDISC standards, where applicable.
• Foster and promote SCHARP initiatives and support of DEI and an Irresistible Organization.
• 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.
• Provide organizational leadership, support collaboration and team building, facilitate cross-group interactions and projects, and identify infrastructure and technological needs.
• Evaluate and identify efficiencies and process improvements including leading infrastructure and technological upgrades as needed to improve the governance, security, and access to SCHARP data assets.
• Oversee the strategy, policies, and SOPs related to data retention, data security, data access and data sharing that align with regulatory and industry requirements.
• Collaborate with stakeholders to identify KPIs related to data governance and monitor performance against the KPIs.
• Represent the interests of the Data Services as a member of SCHARP Senior Management Team.Qualifications Minimum Qualifications Master's degree in Science, Public Health, or similar degree in a scientific, technical, or health-related field with 10+ years of experience in data management, governance, security or related disciplines or equivalent combination of experience and education.At least 5 years of experience in direct staff supervision/management.Extensive leadership experience with expertise in Data GovernanceKnowledge of current IT risks and experience implementing security solutionsKnowledge of clinical research business and regulatory requirements.Ability to work in matrixed environments and to build and sustain collaborative relationships across business and IT rolesAbility to effectively monitor industry and regulatory activities and assess impact on Data Preferred Qualifications
  • Extensive experience and knowledge of human clinical research trials, clinical research industry best practices and regulations.
  • Familiarity with CDISC data standards (CDASH, SDTM, ADaM, and controlled terminology references)
  • Familiarity with GCP, GLP, GCDMP, and CDISC standards.
  • In depth knowledge of clinical trials and data security and privacy regulations (e.g., HIPAA, GDPR, FISMA, ICH and 21 CFR-Part 11, etc.)
    - Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
    As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment. A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists. Our Commitment to Diversity 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. Shop the latest HBCU products in the Marketplace. Bundle up and save! Save big when you combine your car and home insurance with our friends at Nationwide! As one of the world's leading providers of technology, communications and more, Verizon's dynamic network of people is moving the world forward. You can too. Coupa is looking to hire more Black Professionals for careers in I.T., Accounting, Finance, Sales, HR and more but you have to apply today! Let's make a list of the things you love! Whatever is important to you, our friends at Nationwide can help you protect it! Join Us to Learn More About Opportunities on our Internal Communications, Media Relations, and Corporate Events Teams!

Keywords: Fred Hutchinson Cancer Research Center, Seattle , Director, Data Services and Governance, Executive , Seattle, Washington