Senior Manager, Clinical Data Management
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.
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- 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.
- 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
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