Central Monitoring Specialist

3 days ago

Gulbarga, Karnataka, India beBeeCentralMonitoring Full time ₹ 1,20,00,000 - ₹ 1,80,00,000

Job Title: Central Monitoring Strategist

This role serves as a key leader in driving data integrity, patient safety, and operational excellence across clinical development programs through advanced centralized monitoring.

Main Responsibilities:
  • Lead the development of quality management plans, collaborating with cross-functional teams to design comprehensive risk-based quality management strategies.
  • Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
  • Design and oversee the implementation of centralized statistical monitoring frameworks, interpreting complex data patterns and leading root cause analyses.
  • Facilitate regular quality management meetings, bringing together key stakeholders to review and discuss study data, findings, action plans, and data cleaning activities.
  • Ensure high standards of data quality and integrity through proactive monitoring and timely interventions.
  • Work closely with clinical operations, data management, biostatistics, and other departments to support oversight and management of clinical studies.
  • Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
  • Oversee operational metrics, including data entry trends, SDV backlog, site health trending, and proactively communicate issues to study team members.
Qualifications:
  • Bachelor's Degree in a relevant field or 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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