Work Location : Bangalore
Serve as a member of the project team with primary responsibility for performing clinical data review, query generation / resolution and reconciliation activities to support the delivery of clinical data according to client quality and integrity specifications, project timelines and productivity targets
Essential Job Duties:
- Perform all data management tasks as appropriate to include, but not to be limited to: data review and query management to ensure that quality standards (both internal and client) are achieved.
- Perform reconciliation of the clinical database against safety data, laboratory data and other third party data as appropriate.
- Review clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete or implausible data.
- Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database as required.
- Run ancillary programs (diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data
- 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.
- Create or review data listings for dose escalation and safety assessments as needed.
- Assist with creation/reviewing Edit Check Specifications
- Create User Acceptance Test Scripts from Edit Check Specifications and create dummy data to test edit checks and to test database screen functionality
- Assist in creation of Study Test Plan and Study Test Report documentation
- Perform Database Decommissioning and create supportive documentation
- Assist in preparing Access Rights forms for EDC database
- Support team members by creating forms/memos as required
- Filing of Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required.
- Running study status reports
- Performs any other duties as assigned