. Through understanding of the all the study specific documents such as protocol, Case
Report Forms CRFs, data cleaning guidelines, data validation guidelines and the
timelines of study deliverables.
. Responsible for handling discrepancies Query resolution and Query integration in
Database as per protocol. Perform external checks to handle manual discrepancies and
action the same. If required liaise with rd party vendors to clean electronic data for
external data reconciliations.
. Application of selfevident corrections according to relevant guidelines and identification
of protocol violations and reporting them.
. Perform ongoing and final consistency checks, review protocol deviation handling
document and data listings to ensure that all data have been handled appropriately
according to the DMP.
. To freeze, lock data and perform Functional QC as appropriate in time for statistical
review blinded interim quality review, interim and final database lock. Handled Dataset
review according to given guidelines and procedures.
. Conduct of User Acceptance Testing UAT of EDC systems to ensure screening design
matches protocol & edits are programmed & operating as intended & escalate the errors
identified to the CDM study manager.
. Take responsibility for specific tasks on projects, or acts as the main CDA contact on
individual projects and training of study team members on selected tasks. And also
maintenance of local study files in case of global study.
. Attend relevant study teleconference with the Sponsor staff to communicate and address
any study related issues or concerns.
. Communication of Data Trends with the onsite study team and the clinical site
coordinators on the progress of the study.
. Review and resolve data discrepancies identified by the system or through manual checks as
identified in the data editing guidelines.