Clinical Data Management Professional

Designation: Clinical Data Management

Full Time Opportunity

Location: Multiple

Job Description:

- 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.