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Clinical Data Manager I, SCHARP

Clinical Data Manager I, SCHARP

Job ID 
Regular Full-Time
Fred Hutchinson Cancer Research Center
Clinical Research Support Services

More information about this job


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 & Prevention (SCHARP) at Fred Hutch is seeking a Clinical Data Manger I to work with Phase 1-3 clinical trial study teams to develop and deliver quality clinical trial data for the betterment of HIV research worldwide. The Clinical Data Manager I will manage study/protocols with moderate supervision from Senior Clinical Data Managers (Sr. CDM) and/or departmental leadership and will use judgment in making decisions regarding routine data management, quality control and liaison tasks. THE CDM I is the primary SCHARP contact for study/protocol specific implementation, operation, and closeout phases and is responsible study communication, documentation, and training on data collection and management activities for domestic and international research sites for assigned protocol/study(s).  


The CDM I is a member of the protocol/study team coordinating with both internal and external partners and collaborators to ensure the relevant data are collected and cleaned to meet the needs of the protocol/study and research objectives. She/He functions with moderate supervision in operational and technical matters within defined procedures and practices.


  1. Manages study/project implementation including but not limited to leading SCHARP team members through CRF, lab, and other data collection processes, reporting and analysis requirements, study/project documentation and training.
  2. Effectively manage assigned protocol/study, establish timelines and milestones, monitor and communicate ongoing status and progress.
  3. Ensure rapid resolution of issues/problems using appropriate internal and/or external resources. Track and manage issues escalating to the appropriate level in a timely manner.
  4. Participate in development of protocol/study from draft protocol to optimize collection of accurate and high-quality data.
  5. Work with project sponsors, stakeholders and SCHARP team members to define project requirements, scope, risks, staffing requirements, organization and approach.
  6. Act as subject matter expert for data management issues between SCHARP study teams and external domestic and international research sites for assigned studies.
  7. Assist in development of Case Report Forms (CRFs) for assigned studies.
  8. Assist in the design of the protocol/study specific database for assigned studies.
  9. Assist in the maintenance of the study database including routine revisions or additions to include the design and/or modification of routine and existing study database edit check programs for assigned studies.
  10. Perform User Acceptance Testing (UAT) for assigned studies.
  11. Monitor study data to insure the quality and completeness of the data submitted by implementing quality control procedures.
  12. Generate QC reports for site review and correction as well as a variety of other reports as required.
  13. Evaluate study data for protocol compliance.
  14. Assist in the maintenance of documentation of the study database and other related data management programs and/or applications.
  15. Assist in the review of new and revised departmental SOPs and WPGs.
  16. Ensure that SCHARP meets its obligations in accordance with Good Clinical Data Management Practices (GCDMP). 
  17. Perform other duties as assigned.


  • Bachelor’s degree or equivalent, preferably in a health-related or scientific discipline.
  • 2+ years’ experience in the pharmaceutical/clinical research environment as a Clinical Data Manager/Clinical Data Coordinator.
  • EDC experience required. Working knowledge of Medidata Rave highly desirable. Demonstrated expertise in relevant clinical data management activities.
  • Working knowledge of ICH/GCP guidelines and FDA regulations. 
  • Familiarity with all phases of clinical trials and ability to adapt to study requirements.
  • Strong verbal and written communication skills. Ability to understand and follow instructions and guidelines; able to pick up new tasks quickly; willing to ask questions when a task is not fully clear.
  • Ability to exercise independent judgement within generally defined practices and policies. Shows good judgment in interpreting guidelines and when to seek support. 
  • Able to work independently and work efficiently under pressure.
  • Consistent, dedicated, versatile and able to prioritize and multi-task.
  • Familiarity with MS Office Software and familiar with data management practices.

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