Clinical Data Manager

2 months ago


San Jose, California, United States KlinEra Global Services Inc Full time

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



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