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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.
- 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
- 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