Strategic Central Monitoring Lead

3 days ago

Palakkad, Kerala, India beBeeDataDriven Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

The primary role of a Central Monitoring Strategist is to lead the development and implementation of advanced centralized monitoring strategies that drive data integrity, patient safety, and operational excellence across clinical development programs.

This involves shaping and executing enterprise-wide risk-based quality management (RBQM) strategies, conducting complex risk assessments, and defining key risk indicators (KRIs) in collaboration with senior functional leaders.

The Central Monitoring Strategist oversees the design and implementation of centralized statistical monitoring frameworks, leads RBQM governance forums, and ensures proactive risk detection and mitigation across portfolios.

This role provides strategic oversight for high-impact studies and therapeutic areas, guiding cross-functional teams through data-driven decision-making and continuous improvement.

Key Responsibilities:
  • Developing Comprehensive RBQM Plans
  • Conducting Thorough Risk Assessments
  • Designing Advanced Centralized Statistical Monitoring Frameworks
  • Leading RBQM Meetings
  • Ensuring Data Quality Assurance and Oversight
Requirements:
  • A Bachelor's Degree in a relevant field or an equivalent combination of education, training, and experience.
  • A minimum of 8 years of experience in clinical monitoring, clinical trial management, or equivalent.
  • A working knowledge of ICH GCP guidelines and the clinical development process.
Preferred Qualifications:
  • CRO experience as a Central Monitor.
Skills:
  • Statistical analysis and data monitoring.
  • Risk assessment and mitigation.
  • Report writing and presentation.

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