Centralized Clinical Monitoring Specialist

1 day ago


Salem, Tamil Nadu, India beBeeClinical Full time ₹ 1,74,08,001 - ₹ 2,43,11,119

Job Title: Principal Central Monitor

Role Overview:

The role of Principal Central Monitor is a key leadership position within our organization.

Key Responsibilities:
  • Develop and implement risk-based quality management (RBQM) plans in collaboration with cross-functional teams.
  • Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
  • Design and oversee the implementation of advanced centralized statistical monitoring frameworks.
  • Lead facilitation of monthly RBQM meetings to review and discuss study data, findings, action plans, and coordination of data cleaning activities.
  • Evaluate and ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
  • Collaborate closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.
  • Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
Qualifications:
  • Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience.
  • Minimum 8 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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