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 Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Director, Clinical Data Management (CDM) to provide overall leadership and management of the clinical data management and safety teams (consisting of approximately 40 employees) 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 teams are operating efficiently and effectively and that they meet the requirements of the research protocols in a regulatory compliant manner. Director, Clinical Data Management will also work closely with SCHARP's Executive Director, Managing Director and Senior Management Team to create and implement the overall organizational strategic direction, project plans, and initiatives.
Provide overall strategic, organizational, and operational management and guidance to the CDM group.
Collaborate with the SCHARP Executive Director and other unit Directors to create and implement overall organizational vision and strategic direction.
Foster and promote the long-term development of the CDM team, work closely with the SCHARP Executive Director, Senior Management Team, and the CDM managers to improve the operational effectiveness of the group.
Directly supervise Clinical Data Management and Safety and Coding managers, and other CDM staff as needed.
Provide training, direction and performance management for individual employees and work with Fred Hutch Human Resources staff to facilitate recruiting efforts and staffing changes as needed.
Develop and maintain CDM staff morale, engagement, and professional development.
Monitor group project and protocol workflows, priorities, timelines, deliverables, documentation and resources and communicate issues regarding conflicts and/or resource limitations.
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.
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.
Oversee and ensure quality assurance of CDM in coordination with the Quality Management section.
Prioritize and manage the implementation of SCHARP continuous quality improvement, regulatory compliance, operational effectiveness, and technical infrastructure improvement projects in clinical data management.
Evaluate and identify efficiencies and process improvements including leading process improvement projects, and infrastructure and technological upgrades to improve CDM intake, workflow, documentation, tracking, and protocol management
Bachelor's degree in related field and a minimum of 10 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 and best practices.
Graduate Degree in life sciences or related disciplines.
10+ years management experience in a clinical research organization.
Organization strategic planning experience.
Working knowledge of CDISC / CDASH, MedDRA coding, and Medidata Rave EDC.
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