Direct Clinical Data Management team member activities to ensure timely, standard and requirement compliant clinical project deliverables.
Coordinate CRF design as per established standards and applicable protocol.
Build, test and validate clinical database.
Develop and execute SOPs, departmental guidelines and data standards to guarantee database quality control and data management compliance.
Document, verify, validate and execute regulatory compliant programs to perform clinical data management activities.
Engage in study planning to ensure timely commencement of CRF and database design and edit checks.
Guide teams to capture data using methods such as Electronic Data Capture.
Guarantee that user acceptance testing, data transfer requirements and deployment of clinical trial sites are well defined.
Develop requirements of edit checks to guarantee high data quality and develop reports.
Coordinate with clinical research and database analysts in clinical trial databases’ design, development, testing and documentation.
Develop, code and test non-complex data management work products such as data entry screens and database tables.
Manage and track CRF flow and scanning and input required data.
Use problem solving and judgment to apply Clinical Data Management principles.
Update new technology developments and comply with clinical data management associated regulatory issues.
Enter and compile data to generate and develop summary reports and graphics.