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
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– 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.
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