Clinical Data Management Role (2-10 yrs)
Designation: Clinical Data Management
Full Time Opportunity
- Understand and follow study start-up, conduct, and close out activities per the standard process, which will be made known to Service Provider and to the Data Manager in advance and in writing by Baxter.
- Act as a single point of contact from the Service Provider for the studies as assigned
- Prepare/review eCRFs, Edit checks, and Custom Functions requirement document
- Prepare or review edit checks requirement and functional test script document
- Perform functional testing for eCRF/edit checks and Custom Functions
- Identify reports and DM Tables requirements and prepare a report specification document
- Review and provide feedback for study conduct activities performed by the Service Provider peer data reviewer as and when required
- Train Study Team / Sites on EDC
- Perform Query management and manage manual edits checks follow-up messages, etc.
- Performing AE reconciliation and preparing material for AE reconciliation meeting and schedule it
- Provide inputs to Data Review Plan.