Central Monitoring Strategist

1 day ago

Kolkata, West Bengal, India beBeeRiskManagement Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Central Monitoring Leader

We are seeking an accomplished Central Monitoring Leader to drive data integrity, patient safety, and operational excellence across clinical development programs. As a strategic leader, you will be responsible for shaping and executing enterprise-wide risk-based quality management strategies.

This role is accountable for leading complex risk assessments, defining key risk indicators, and collaborating with senior functional leaders to design and implement centralized statistical monitoring frameworks.

The successful candidate will oversee the implementation of proactive risk detection and mitigation across portfolios, provide strategic oversight for high-impact studies, and guide cross-functional teams through data-driven decision-making.

In addition to managing escalations and complex data review activities, the Central Monitoring Leader will mentor senior & junior colleagues, contribute to global process innovation, and play a key role in shaping policies, tools & technologies that enhance centralized monitoring capabilities.

Key Responsibilities:
  • Develop Risk-Based Quality Management Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's needs.
  • Conduct Study Risk Assessments: Identify potential issues and develop mitigation strategies for clinical studies.
  • Implement Advanced Statistical Monitoring: Design and oversee the implementation of advanced centralized statistical monitoring frameworks.
  • Lead Risk Management Meetings: Facilitate monthly RBQM meetings to review and discuss study data, findings, action plans, and coordinate data cleaning activities.
  • Ensure Data Integrity: Proactively monitor and timely intervene to ensure the highest standards of data quality.
  • Cross-Functional Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management.
  • Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
Qualifications:

Minimum Requirements:

  • Bachelor's Degree in a relevant field or equivalent combination of education, training, and experience.
  • Minimum 8 years of experience in clinical monitoring, clinical trial management, or equivalent.
  • 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
  • Collaboration and teamwork
Keyword:

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