Project Management toolkit; Ensure that database design is consistent with 21 CFR part 11; Provide input to the development of case report forms, in conjunction with Clinical Research and Clinical Data Specialists; Annotate CRFs and develop study clinical databases using Oracle Clinical or other clinical database; In conjunction with Clinical Data Specialists, write study specific data entry work instructions; In conjunction with the Validation team, ensure databases are validated and data entry training has been provided before the database is activated; With Clinical Research staff and Clinical Data Specialists, contribute to the development of data edit check rules
Requirements:
Bachelors’ degree required. Management, Psychology, Information science, public health, or life science preferred; Minimum of 3 years’ experience in clinical research and database programming; prefer at least 1 year in device or pharmaceutical clinical trials as a clinical programmer performing mentioned above functions using SAS, Oracle Clinical or Clintrial and/or ACCESS
Text:
Sr. Statistician Project Management toolkit; Ensure that database design is consistent with 21 CFR part 11; Provide input to the development of case report forms, in conjunction with Clinical Research and Clinical Data Specialists; Annotate CRFs and develop study clinical databases using Oracle Clinical or other clinical database; In conjunction with Clinical Data Specialists, write study specific data entry work instructions; In conjunction with the Validation team, ensure databases are validated and data entry training has been provided before the database is activated; With Clinical Research staff and Clinical Data Specialists, contribute to the development of data edit check rules Bachelors’ degree required. Management, Psychology, Information science, public health, or life science preferred; Minimum of 3 years’ experience in clinical research and database programming; prefer at least 1 year in device or pharmaceutical clinical trials as a clinical programmer performing mentioned above functions using SAS, Oracle Clinical or Clintrial and/or ACCESS
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