Job Description: The Clinical Data Manager (CDM) will be responsible for overseeing the data management process for clinical trials, ensuring the accuracy, integrity, and timely delivery of clinical trial data. The role involves collaboration with biostatisticians, programmers, and clinical study teams to support data analysis and reporting activities while ensuring adherence to regulatory requirements. Key Responsibilities: Create comprehensive DMPs that outline processes for data collection, validation, and cleaning, ensuring adherence to protocol specifications and regulatory standards. Design and implement data validation checks and edit checks to ensure the accuracy and completeness of clinical trial data. Oversee the design, development, and validation of clinical trial databases (e.g., EDC systems), ensuring setup aligns with protocol specifications and regulatory requirements. Ensure timely and accurate data entry by closely monitoring data management processes and managing data collection activities. Perform regular data cleaning activities, address data discrepancies, and ensure data is ready for database lock. Conduct quality control checks to identify and resolve data quality issues, ensuring high standards of data integrity throughout the trial. Work closely with biostatisticians, programmers, and clinical study teams to support data analysis, reporting, and regulatory submissions. Generate data listings, summaries, and reports to support clinical study teams and regulatory bodies. Coordinate data management activities across multiple clinical trials, ensuring that timelines and milestones are met. Communicate effectively with both internal and external stakeholders regarding data management activities, providing regular updates and addressing any concerns. Maintain accurate and complete documentation for all data management processes, ensuring compliance with SOPs and regulatory guidelines. Ensure all data management activities comply with ICH/GCP guidelines, SOPs, and relevant regulatory requirements, including FDA guidelines. Required Education/ Experience: Bachelor’s degree in Life Sciences or a related field; advanced degree preferred. Minimum of 3+ years of experience in the clinical research industry. Strong understanding of clinical data management principles and practices. Experience with Electronic Data Capture (EDC) systems and clinical trial databases. Preferred Skills: Proficiency in data management software and tools. Strong analytical and problem-solving abilities, with the ability to troubleshoot and resolve data issues. Thorough knowledge of FDA, ICH/GCP and DCGI regulations, and data management best practices in clinical trials. Experience with data validation checks, edit checks, and quality control in clinical trials. What We Offer: Competitive salary and benefits package. Professional development and growth opportunities. Collaborative and innovative work environment. #J-18808-Ljbffr Initial Therapeutics, Inc.
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