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Senior Clinical Data Manager

3 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 5+ years of experience in clinical data management, with at least 3+ years in a leadership or senior role
  • In-depth knowledge of clinical trial processes, data management methodologies, and regulatory requirements
  • Proficiency in data management software
  • Strong leadership capabilities with a proactive and adaptable approach.
  • Ability to work effectively under pressure and manage multiple priorities.

    Responsibilities
    • Lead and manage the clinical data management activities for assigned clinical trials or projects.
    • Collaborate with cross-functional teams including clinical operations, biostatistics, and regulatory affairs to ensure data integrity and quality.
    • Develop data management plans (DMPs) and oversee their implementation to ensure efficient data collection, validation, and cleaning.
    • Define and implement data validation checks and edit checks to maintain data quality.
    • Perform data review and validation activities to ensure accuracy and completeness of clinical trial data.
    • Generate and review data listings, summary tables, and data visualizations for clinical study reports.
    • Ensure adherence to relevant regulatory guidelines (e.g., FDA, ICH GCP) and industry standards for clinical data management.
    • Implement and maintain SOPs related to clinical data management processes.
    • Provide mentorship and leadership to junior data management staff.
    • Conduct training sessions on data management processes and systems for team members and stakeholders.
    • Evaluate and recommend new data management technologies and tools to enhance efficiency and quality.
    • Stay updated with industry trends and best practices in clinical data management.
    • Act as a key point of contact for data management issues and queries from internal and external stakeholders.
    • Facilitate data management meetings and contribute to cross-functional project teams.