Maria abu

Senior Clinical Data Manager @Rho

Maintained data management plan • Worked with the study team, designed, and developed case report forms, in collaboration with the eCRF programmer • Tested and validated the programming of electronic data capture (EDC) systems, registries, web sites and other informatics systems, products, and integration • Developed specifications and where possible, program reports for monitoring studies, project reporting, and analysis of clinical trial data • Coordinated data collecting from multiple sources including EDC data extraction, data from external vendors, e.g, central laboratories • Reconciled data from multiple data sources and resolve any discrepancies • Reviewed study data to ensure timeliness, completeness, and accuracy to have the highest possible level of research study data integrity • Developed data queries for any questionable data and monitored the accurate and complete resolution of all data queries • Monitored clinical site efficiency and effectiveness in data capture, data management and data integrity monitoring • Managed user request for systems modifications and report development • Troubleshoot system/software problems through resolution • Trained users on the operation of systems, tools, and data management/data integrity monitoring procedure • Ensured that external and internal regulations and policies governing data management and data systems are met including but not limited to GCP, FDA and organizational SOPs • Worked closely with the Principal Investigator and research team and participate in team conferences and meetings. • Developed policies and procedures and best practice methodologies • Worked with information technology staff and others to facilitate automation of standard, recurrent data acquisition, management, analysis, and reporting • Assisted in the development of methodologies to conduct data tracking and quality assurance and assisted in establishing data standards