Responsibilities:
- Ensures that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
- Demonstrates capability to read and follow study timelines for on-time deliverables.
- Potential to assist with inputs on study design or capable to make suggestions to study timelines when warranted.
- 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.
- 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 QC data listings for internal data review.
- May assist or create dummy data to test edit checks and to test database screen design and functionality.
- Assist or create dummy data to test SAS reports and data listings.
- 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 requests.
- Assist with the completion of Database Lock and Unlock activities.
- Supports the training of new staff on project specific Data Management processes.
- Performs any other duties as assigned.
