• Clinical Data Manager II-Immunotherapy

    Job ID 2019-30192
    Area of Interest
    Research & Development
    Location Name
    Metropolitan Park West
    FTE/Hours per pay period
    1.0 FTE (80 hours per bi-weekly pay periods)
    Work Status
    Regular
    Department
    Immunotherapy Integration Hub
    Shift
    Day Shift
  • Overview

     The Immunotherapy Integration Hub at Seattle Children's Research Institute (SCRI) seeks to develop innovative new cellular therapies and translate these advances to groundbreaking clinical trials for children with the most aggressive forms of cancer. The Center's long-term mission is to eventually replace cancer therapies such as radiation and chemotherapy with "smart" therapies capable of eliminating cancer with precision, leaving the body unharmed.
    This is an opportunity for a Clinical and Lab Data Management Specialist II to join the Data Management Team at Immunotherapy Coordinating Center. Responsibilities will include clinical and lab data management support for early phase single and multi-site, pediatric Immunotherapy clinical trials. The data management responsibilities will span from study concept development through closure, including creating data specification, database build, data maintenance, study material development, study closeout activities and vendor management.

    Requirements

    Required Education/Experience:
    - Bachelor's Degree in a scientific discipline or related field.
    - Minimum of four (4) years experience in clinical study operations, including at least three (3) years of clinical data management.
    - Understanding of relational database principles.
    - Minimum two (2) years experience creating specifications for all aspects of a database build.

    Preferred:
    - Master’s Degree in scientific discipline or related field
    - Database build experience in Medidata Rave
    - Advanced SQL query skills
    - Applied knowledge of CDISC/CDASH/SDTM
    - Experience with clinical dictionaries; MedDRA and WHO dictionaries are preferred
    - Applied knowledge of Medidata Coder
    - Experience in Labkey

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