Data Integrity Specialist

2 days ago

Vellore, Tamil Nadu, India beBeeClinical Full time ₹ 18,00,000 - ₹ 25,00,000
Monitoring Specialist Position

The Monitoring Specialist plays a pivotal role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.

  • This position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study Key Risk Indicators (KRIs), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings.
  • Monitoring Specialists work independently and manage report review and issue escalation for more complex studies and/or portfolios of work.

Furthermore, the Monitoring Specialist may mentor junior colleagues and support the development of processes, procedures, and other documentation to ensure a high-functioning team.

Key Responsibilities:
  • Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies in consultation with functional team leads and Project Managers.
  • Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
  • RBQM Meetings: Support monthly RBQM meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities to support study deliverables.
  • Data Quality Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
  • Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.
  • Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
  • Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending, and proactively communicate issues to study team members to drive towards resolution and proactive remediation.
Requirements:
  • Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience.
  • Minimum 2 years 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.

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