Technical Knowledge Required for Clinical Data Manager: 1. Data Management Systems: Proficiency in working with various data management systems used in clinical trials, such as Electronic Data Capture (EDC) systems, Clinical Data Management Systems (CDMS), and Clinical Trial Management Systems (CTMS). 2. Data Standards: Understanding and application of data standards, such as CDISC (Clinical Data Interchange Standards Consortium) standards, including CDASH (Clinical Data Acquisition Standards Harmonization) and SDTM (Study Data Tabulation Model). 3. Data Validation: Knowledge of data validation techniques, including data cleaning, query management, and discrepancy management to ensure data accuracy and integrity. 4. Database Design: Familiarity with database design principles and relational database management systems (RDBMS) to effectively design and manage clinical trial databases. 5. Programming Languages: Basic programming skills in languages like SQL (Structured Query Language) and SAS (Statistical Analysis System) to perform data manipulations, transformations, and analysis. 6. Statistical Concepts: Understanding of statistical concepts and methodologies used in clinical trials, such as randomization, sample size calculation, and statistical analysis plans. 7. Regulatory Guidelines: Knowledge of regulatory guidelines and requirements, including Good Clinical Practice (GCP) guidelines, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, and local regulatory requirements. 8. Data Privacy and Security: Awareness of data privacy and security regulations, such as Health Insurance Portability and Accountability Act (HIPAA) and General Data Protection Regulation (GDPR), to ensure compliance in handling sensitive patient data. 9. Quality Control: Understanding of quality control processes and procedures to ensure data quality and adherence to standard operating procedures (SOPs) and regulatory guidelines. 10. Project Management: Basic project management skills to effectively plan, organize, and coordinate data management activities within clinical trials. 11. Communication and Collaboration: Strong communication and collaboration skills to work effectively with cross-functional teams, including clinical researchers, biostatisticians, programmers, and regulatory authorities. 12. Problem-Solving: Ability to identify and resolve data management issues and challenges that may arise during clinical trials. 13. Continuous Learning: Willingness to stay updated with the latest advancements and trends in clinical data management, including new technologies, regulatory changes, and industry best practices. It is important to note that the specific technical knowledge required may vary depending on the organization, the complexity of clinical trials, and the specific role of the Clinical Data Manager.