Senior Data Integrity Specialist

11 hours ago

Tiruppur, Tamil Nadu, India beBeeDataQuality Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Centralized Monitoring Leader

This is a key role in driving data integrity and patient safety across clinical development programs. The successful candidate will have expertise in advanced centralized monitoring and risk-based quality management (RBQM). They will shape and execute enterprise-wide RBQM strategies, leading complex risk assessments and defining key risk indicators (KRIs).

The Centralized Monitoring Leader oversees the design and implementation of statistical monitoring frameworks, leads 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.

  • Develop Comprehensive RBQM Plans: Collaborate with cross-functional teams to design tailored plans that address each study's needs.
  • Risk Assessment: Conduct thorough assessments to identify potential issues and develop mitigation strategies.
  • Advanced Statistical Monitoring: Design and oversee the implementation of advanced statistical monitoring frameworks.
  • RBQM Meetings: Lead facilitation of monthly meetings to review and discuss study data, findings, action plans, and coordination of data cleaning activities.
  • Data Quality Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.

Mentor junior colleagues and contribute to global process innovation.

Shape policies, tools, and technologies to enhance centralized monitoring capabilities.

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.
Key Skills:
  • Statistical analysis and data monitoring.
  • Risk assessment and mitigation.
  • Report writing and presentation.

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