• Clinical Data Manager III

    Job ID
    10924
    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 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 III 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 CDM III leads the SCHARP project/study team coordinating with both internal and external partners and collaborators to ensure the relevant data are collected to meet the needs of the project or research objectives.S/he uses best practices for project management. The CDM III is the primary SCHARP contact for protocol/project implementation, operation, and closeout phases and is responsible for communication, documentation, and providing training on data collection and management activities for domestic and international research sites.

     

    S/he functions with minimal supervision with demonstrated decision-making ability in operational and technical matters within defined procedures and practices. The CDM III will have advanced knowledge of data management operations best practices and network-specific activities. S/he may participate in training and orientation of new CDMs when appropriate, and may serve as a CDM mentor.

     

    Assignment of projects/trials is commensurate with previous experience and can be assigned across scientific areas or study phases. S/he will be coordinating larger, more complex studies and/or a larger volume of studies with minimal assistance.

    Responsibilities

    1. Manage 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. Prepare status reports and keep study/project sponsors, team, SCHARP management, and stakeholders informed of status and issues.
    18. Coordinate Safety/Study Monitoring Committees or Data and Safety Monitoring Board review process, as applicable.
    19. Coordinate approved requests for changes to scope of work according to defined change control procedures.
    20. Close studies/projects ensuring that all project work has been fully completed, documented and stored.
    21. Perform other duties as assigned.

    Qualifications

    • Bachelor’s degree or equivalent, preferably in a health-related or scientific discipline.
    • 6+ years’ experience in the pharmaceutical/clinical research environment as Clinical Data Manager.
    • EDC experience required. Working knowledge of Medidata Rave highly desirable. Demonstrated expertise in relevant clinical data management activities.
    • Experience using SAS and relational databases (e.g. MS SQL Server, MS Access, or Oracle)
    • Experience in clinical trial and regulated research settings desired.
    • Experience with managing immunology, infectious disease and/or virology research projects desired. Prior experience in HIV or infectious diseases clinical trial operation management and/or protocol development preferred.  
    • Familiarity with all phases of clinical trials and ability to adapt to study requirements.
    • Demonstrated problem-solving skills. Self-motivated and able to work independently using strong organizational, project and time management skills.
    • Experience in facilitating and building consensus in an interdisciplinary team environment and able to build successful working relationships with a wide variety of collaborators.
    • Strong written and oral communication skills.
    • Proficient with MS Office software and familiar with data management practices.  Familiarity with project management software desirable.
    • Ability to work independently and to work efficiently under pressure. 
    • Consistent, dedicated, versatile and able to prioritize and multi-task.
    • Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related 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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