Central Data Quality Specialist II

4 days ago

Vijayawada, Andhra Pradesh, India beBeeQuality Full time ₹ 18,00,000 - ₹ 24,00,000
Job Title: Central Data Quality Specialist II

Central Data Quality Specialist II plays a crucial role in ensuring the quality and integrity of clinical trial data. This position involves leading centralized monitoring activities, statistical data review, and proactive risk management. The key responsibilities include developing Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study Key Risk Indicators (KRIs), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings.

Key Responsibilities:
  • Develop and implement RBQM plans to ensure high-quality clinical trial data.
  • Conduct thorough risk assessments for clinical studies to identify potential issues and develop mitigation strategies.
  • Perform centralized statistical monitoring and data analysis to detect anomalies, trends, and potential risks.
  • Facilitate monthly RBQM meetings to review study data, document findings, and coordinate data cleaning activities.
  • Ensure highest standards of data quality and integrity through proactive monitoring and timely interventions.
Requirements:
  • Bachelor's Degree in a relevant field or equivalent combination of education and experience.
  • Minimum 2 years experience in clinical monitoring, clinical trial management or equivalent.
  • Working knowledge of ICH GCP guidelines and the clinical development process.
Skills:
  • Statistical analysis and data monitoring.
  • Risk assessment and mitigation.
  • Report writing and presentation.
  • Collaboration and teamwork.
About Us:

We are an Equal Opportunity Employer and value diversity in our workforce.

If you have any questions or require assistance with your application, please contact us.

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