Clinical Data Coordinator ..Saviance Technologies - Bangalore..'R"

Clinical Data Coordinator
Saviance Technologies - Bangalore, Karnataka

Understand and comply with all applicable standard operating procedures (SOPs) (departmental company level) and working instructions Ensure completeness and validity of the clinical trial data that has gone through data entry. Extensive familiarity with data management processes on paper based and Electronic Data Capture (EDC) studies. Review and resolve discrepancies identified by the automated manual checks as per the validation guidelines. Issue DCFs/DRFs as and when required, review the responses and update database appropriately as per standard timelines. Ensure the quality and consistency of coding discrepancy handling and ensure that it is accomplished in a timely manner Perform SAE reconciliation and Third Party Vendor Data reconciliations. Issue DCFs/DRFs as needed and update the clinical database or inform the respective teams for necessary action. Perform tracking and entry of CRF/e-CRF data into the clinical databases. Collaborate with global data management team on various data management related activities on global studies. Provide status reports on data entry, validation and any difficulties for on-going projects to Lead Data Manager. Interact with Data Management team to report on the quality of data collection, identify trends and any site issues. Ensure that at the end of the clinical trial, all the Data clarification forms are resolved, all data is "cleaned" and the data is locked as per the deadline of the trial. Provide support to Lead Clinical Data Manager in User Acceptance Testing (UAT) of data entry screens and validation edit checks. Provide support to Lead Clinical Data Manager in study specific documentation and Biometrics TMF maintenance. Training and Mentoring new employees. Candidate needs to be very strong in Data ValidationCLICK HERE TO VIEW /APPLY