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Responsibilities
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- Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
- Demonstrate capability to read and follow study timelines for on-time deliverables.
- Assist with inputs on study design or suggest adjustments to study timelines when warranted.
- Review clinical trial data in accordance with Data Management Plans and/or Data Review Guidelines and raise queries to resolve erroneous, missing, or incomplete data.
- Run and execute additional programs (special listings, reconciliation discrepancy listings, etc.) to support the review of clinical trial data.
- Generate, resolve, and track queries to address problematic data identified during aggregate data review activities.
- Interact 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 QC data listings for internal data review.
- Assist with or create dummy data to test edit checks and database screen design and functionality.
- Assist with or create dummy data to test SAS reports and data listings.
- 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.
- Run study status reports in preparation for Sponsor meetings and to deliver on specific sponsor requests.
- Assist with the completion of Database Lock and Unlock activities.
- Support the training of new staff on project-specific Data Management processes.
- Perform any other duties as assigned.
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