Daily Responsibilities of a Clinical Data Manager: 1. Data Collection and Validation: - Collecting and organizing clinical trial data from various sources. - Ensuring the accuracy and completeness of collected data. - Verifying data against source documents and resolving discrepancies. 2. Database Management: - Designing and implementing databases to store clinical trial data. - Developing data entry guidelines and standards. - Ensuring data integrity and security. - Performing regular data backups. 3. Data Cleaning and Quality Control: - Conducting data cleaning activities to identify and resolve errors or inconsistencies. - Implementing quality control procedures to maintain data accuracy and reliability. - Reviewing data for compliance with regulatory requirements and study protocols. 4. Data Analysis and Reporting: - Analyzing clinical trial data using statistical software. - Generating reports and summaries for study investigators and regulatory authorities. - Identifying trends, patterns, and outliers in the data. - Assisting in the preparation of study publications and presentations. 5. Collaboration and Communication: - Collaborating with cross-functional teams, including biostatisticians, clinical researchers, and regulatory affairs personnel. - Participating in meetings and discussions related to data management. - Communicating with study sites and investigators to address data-related queries or concerns. 6. Compliance and Regulatory Oversight: - Ensuring compliance with regulatory guidelines, such as Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines. - Assisting in the preparation of regulatory submissions. - Participating in audits and inspections related to data management practices. 7. Continuous Improvement: - Staying updated on industry trends, best practices, and emerging technologies in clinical data management. - Identifying opportunities for process improvement and implementing efficient data management strategies. - Participating in training programs to enhance skills and knowledge in data management. 8. Documentation and Standardization: - Creating and maintaining documentation related to data management processes, procedures, and protocols. - Ensuring adherence to standard operating procedures (SOPs) and data management guidelines. - Contributing to the development and enhancement of data management tools and templates. Please note that the specific responsibilities may vary depending on the organization, study phase, and therapeutic area.