Senior Clinical Data Integrity Manager

7 days ago

Bengaluru, Karnataka, India beBeeClinicalTrial Full time ₹ 1,20,00,000 - ₹ 1,50,00,000
Quality Assurance Specialist

The Quality Assurance Specialist plays a vital role in ensuring the integrity and quality of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.

Key Responsibilities:
  1. Develop Risk-Based Quality Management (RBQM) plans collaboratively with cross-functional teams.
  2. Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
  3. Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks.
  4. Facilitate monthly RBQM meetings by supporting review of study data, documenting findings, action plans, and coordination of data cleaning activities.
  5. Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
  6. Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management.
  7. Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.

This position involves leading complex projects, mentoring junior colleagues, and supporting the development of processes, procedures, and documentation to ensure a high-functioning team.

Requirements:
  • Bachelor's Degree in a relevant field or equivalent combination of education, training, and experience.
  • Minimum 5 years experience in clinical monitoring, clinical trial management, or equivalent.
  • Working knowledge of ICH GCP guidelines and the clinical development process.
  • Excellent communication, organizational, and time management skills.
  • Strong understanding of RBQM principles and methodologies.

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