The Clinical Data Management Specialist II will be responsible for clinical and lab data management support for early phase single and multi-site, pediatric Immunotherapy clinical trials. 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. 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.
- Bachelor’s Degree in 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.
- Minimum two (2) years experience creating specifications for all aspects of a database build.
- Understanding of programming & relational database principals.
- 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.
- Applied knowledge of Medidata Coder.
- Experience in Labkey.