Clinical Data Integrity Specialist

11 hours ago

Vizag, Andhra Pradesh, India beBeeDataIntegrity Full time ₹ 90,00,000 - ₹ 1,20,00,000
Clinical Data Integrity Specialist

This role plays a pivotal part in ensuring the accuracy and reliability of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management strategies.

Key Responsibilities:
  • Develop Risk-Based Quality Management (RBQM) plans to mitigate potential issues and ensure compliance with regulatory requirements.
  • Conduct study risk assessments to identify potential risks and anomalies in clinical trial data.
  • Perform centralized statistical monitoring and data analysis to detect anomalies and risks in clinical trials.
  • Facilitate regular RBQM meetings to ensure data accuracy, integrity, and compliance with regulatory guidelines.
  • Mentor junior colleagues and support process development to improve clinical trial operations.
Requirements:
  • Bachelor's degree in life sciences, statistics, data management, or clinical operations, preferably with a strong focus on data quality and integrity.
  • Minimum 2 years experience in clinical monitoring or clinical trial management, with a proven track record of ensuring data accuracy and reliability.
  • Working knowledge of ICH GCP guidelines and the clinical development process, including regulatory requirements and industry standards.
  • Excellent communication, organizational, and time management skills, with the ability to work effectively in a team environment.

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