Tasks expected from Clinical Data Managers: - Data Collection: Clinical Data Managers are responsible for collecting and organizing clinical trial data from various sources, such as electronic health records, case report forms, and laboratory results. - Data Entry and Validation: They enter the collected data into electronic databases and ensure its accuracy and completeness by performing data validation checks and resolving any discrepancies. - Data Cleaning: Clinical Data Managers clean the data by identifying and correcting errors, inconsistencies, and missing information to ensure data quality and integrity. - Data Standardization: They standardize the collected data by applying coding systems, such as Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization Drug Dictionary (WHO-DD), to facilitate analysis and reporting. - Data Security and Confidentiality: Clinical Data Managers ensure the security and confidentiality of clinical trial data by implementing appropriate data protection measures and adhering to regulatory guidelines. - Data Query Management: They manage data queries by reviewing and resolving discrepancies or inconsistencies in the data through communication with study sites, investigators, and other relevant parties. - Data Analysis and Reporting: Clinical Data Managers assist in data analysis by generating reports, performing statistical analyses, and creating data visualizations to support clinical trial outcomes and decision-making. - Data Auditing and Quality Control: They participate in data audits and quality control activities to ensure compliance with regulatory requirements and internal data management standards. - Database Development and Maintenance: Clinical Data Managers contribute to the development and maintenance of electronic databases used for data collection, storage, and retrieval. - Collaboration and Communication: They collaborate with cross-functional teams, including clinical researchers, statisticians, and regulatory affairs personnel, and communicate effectively to ensure smooth data management processes throughout the clinical trial lifecycle.