Chief Data Integrity Specialist

3 days ago

Jamnagar, Gujarat, India beBeeClinical Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Overview

The Principal Central Monitor assumes a strategic leadership position, driving data integrity, patient safety, and operational excellence across clinical development programs via advanced centralized monitoring and risk-based quality management.

This role is accountable for shaping and executing enterprise-wide RBQM strategies, leading complex risk assessments, and defining key risk indicators (KRIs) in collaboration with senior functional leaders.

The Principal Central Monitor 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:
  • Develop Risk-Based Quality Management Plans: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's needs.
  • Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
  • Advanced Statistical Monitoring: Design and oversee the implementation of advanced centralized statistical monitoring frameworks.
  • RBQM Meetings: Lead facilitation of monthly RBQM meetings to review and discuss study data, findings, action plans, and coordination of data cleaning activities.
Qualifications and Skills
  • 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.
Benefits and Opportunities

This role offers a unique opportunity to drive innovation and excellence in clinical development, working closely with senior leaders to shape the future of RBQM.

Additional Information

Please note that this job description serves as a general guide and may be subject to change based on business needs.

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