Clinical Data Manager
2 months ago
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
- Develop data management plans (DMPs) outlining data collection, validation, and cleaning processes
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