Clinical Data Manager

Clinical Data Manager !!!

Mumbai

3 to 8 Years

Start-up, Conduct, Closeout

Any Life Science Graduate

Roles & Responsibilities

• Review and understand the study protocol and the timelines.
• Perform data review, data reconciliation and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate.
• Implement study team feedback as required on the data.
• Perform external checks to handle manual discrepancies and action the same.
• Develop specifications, implementation and testing for the edit checks and listings (DVS)
• Perform UAT for database
• Develop study specific procedures documents
• Ensure effective implementation of standard metric and status reporting on the study
• Ensure an error free, quality data with no open queries.
• Maintain data management study files and documentation
• Attend and provide an update for data management services at cross-functional study team meetings both internally and with the sponsor
• Identify out of scope tasks and bring to the attention of the TDM
• Assist the TDM in all study set up activities.
• Provide all study related reports to the TDM as per the request .
• Perform SAE reconciliation and Vendor data reconciliation