Central Data Integrity Manager

1 day ago

Bengaluru, Karnataka, India beBeeClinicalData Full time ₹ 80,00,000 - ₹ 1,50,00,000
Clinical Data Integrity Specialist

The Central Monitor II plays a vital role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. This key position requires meticulous attention to detail, strong analytical skills, and excellent communication abilities.

Key Responsibilities:
  • Develop and Implement Quality Management Plans: Collaborate with cross-functional teams to design and implement Risk-Based Quality Management (RBQM) plans that ensure data accuracy and compliance.
  • Conduct Thorough Risk Assessments: Identify potential issues and develop mitigation strategies to minimize risks and maximize data quality.
  • Perform Centralized Statistical Monitoring: Conduct thorough analysis of study data to detect anomalies, trends, and potential risks, providing actionable insights to inform business decisions.
  • Support Proactive Oversight: Collaborate with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management, ensuring seamless integration of processes.
Requirements:
  • Education and Experience: Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations), along with minimum 2 years experience in clinical monitoring, clinical trial management, or equivalent.
  • Skills and Qualifications: Working knowledge of ICH GCP guidelines, clinical development process, and statistical analysis and data monitoring.
Preferred Qualifications:
  • CRO Experience: Previous experience as a Central Monitor in a Contract Research Organization (CRO) environment is highly desirable.
Essential Skills:
  • Statistical Analysis: Strong understanding of statistical concepts and ability to apply them in a clinical trial setting.
  • Risk Assessment: Excellent analytical skills to identify potential risks and develop effective mitigation strategies.
  • Report Writing and Presentation: Ability to communicate complex data insights effectively through clear and concise reports and presentations.

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