Data Integrity Specialist

1 week ago

Bareilly, Uttar Pradesh, India beBeeClinicalMonitor Full time ₹ 12,00,000 - ₹ 15,00,000
Central Monitoring Expert

This role plays a crucial part in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.

Main Responsibilities
  1. Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM.
  2. Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
  3. RBQM Meetings: Support monthly RBQM meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities to support study deliverables.
  4. Data Quality Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
  5. Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.
  6. Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
  7. 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 & proactive remediation.
Requirements
  1. Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience.
  2. Minimum 2 years experience in clinical monitoring, clinical trial management, or equivalent.
  3. Working knowledge of ICH GCP guidelines and the clinical development process.
Essential Skills
  1. Statistical analysis and data monitoring.
  2. Risk assessment and mitigation.
  3. Report writing and presentation.
  4. Collaboration and teamwork.

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