Data Integrity Specialist

4 days ago

Kannur, Kerala, India beBeeClinical Full time ₹ 15,00,000 - ₹ 25,00,000
Central Monitor II

The Central Monitor II plays a pivotal role in ensuring data quality and integrity through centralized monitoring activities, statistical analysis, and proactive risk management.

This position requires a skilled professional with expertise in clinical trial data management, statistical analysis, and risk assessment. The ideal candidate will have a strong background in life sciences, statistics, or a related field, as well as excellent communication and collaboration skills.

The Central Monitor II will lead the development and implementation of Risk-Based Quality Management (RBQM) plans, conduct study risk assessments, and identify potential issues and develop mitigation strategies.

Additionally, this role will involve performing centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.

The successful candidate will support monthly RBQM meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities.

This position also involves evaluating data quality, collaborating with various departments, and preparing detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.

Requirements for this role include:

  • Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, 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.

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