Clinical Data Specialist Full-time Job

Assist with review of clinical trial data in accordance with Data Management Plans and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data. Demonstrates capability to read and follow study timelines for on-time deliverables and potential to assist with inputs on study design or capable to make suggestions to study timelines when warranted. Run and execute additional programs (special listings, reconciliation discrepancy listings, etc.) used to support the review of clinical trial data. Generate, resolve, and track queries to address problematic data identified during aggregate data review activities. Interacts with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as required. Generate and QCs data listings for internal data review. May assist or create dummy data to test edit checks and to test database screen design/functionality, SAS reports and data listing. Demonstrates the ability to review Edit Check Specifications and Database specifications. Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required. Runs study status reports in preparation for Sponsor meetings and to deliver on specific Sponsor request. Assist with the completion of Database Lock and Unlock activities. Supports the training of new staff on project specific Data Management processes.

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