Clinical Data Associate/Clinical Data Manager
Tech Observer - Toronto, ON

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The client is seeking a self-motivated individual to join the Data Management team as a Clinical Data Associate (CDA). As a member of the team the CDA will be responsible for supporting all aspects of the data management process while also having the opportunity to further develop industry experience and knowledge.

General Responsibilities:

  • Support development of DM study documentation, including: Data Management Plans, annotated CRFs and specifications, CRF Completion Guidelines, Data Transfer Plans, etc.
  • Support User Acceptance Testing of Database
  • System and Non-system edit check use and testing
  • Support medical coding and facilitate reviews
  • Support SAE Reconciliation
  • Support data cleaning activities
  • Provide DM infrastructure support as needed (i.e. policy development, Lab Normal database)
  • Support CRO oversight for outsourced studies

Requirements:

  • B.S., B.A. in relevant field with a minimum of ~2-5 of Data Management experience in a biotech/pharmaceutical setting
  • Previous EDC and/or SAS experience desired
  • Strong working knowledge of MS Office
  • Ability to work independently and with a team
  • The successful candidate will be self-motivated and able to multi-task effectively
  • Strong interpersonal skills in a team environment

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