Clinical Data Manager

Qualifications

• Bachelor's degree in life science/related field, advanced degree preferred
• Minimum of 3+ years in clinical research industry
• Knowledge of clinical data management principles, practices, and regulatory requirements (FDA, ICH/GCP)
• Experience with Electronic Data Capture (EDC) systems and clinical trial databases
• Proficiency in data management software and tools
• Strong analytical and problem-solving abilities

Responsibilities

• Develop data management plans (DMPs) outlining data collection, validation, and cleaning processes
• Define data validation checks and edit checks to ensure data quality
• Oversee the design, development, and validation of clinical trial databases (e.g., EDC systems)
• Ensure databases are set up according to protocol specifications and regulatory requirements
• Monitor and manage data entry activities to ensure accurate and timely data collection
• Perform data cleaning activities, resolve data discrepancies, and ensure database lock readiness
• Conduct quality control checks on clinical trial data to identify and resolve data quality issues
• Collaborate with biostatisticians and programmers to support data analysis and reporting activities
• Generate data listings, summaries, and reports for clinical study teams and regulatory submissions
• Coordinate data management activities across multiple clinical trials and ensure timelines are met
• Communicate effectively with internal and external stakeholders regarding data management activities
• Maintain accurate and complete documentation related to data management activities
• Ensure adherence to Standard Operating Procedures (SOPs), ICH/GCP guidelines, and regulatory requirements