Clinical Trial Data Specialist

4 days ago

Rajahmundry, Andhra Pradesh, India beBeeDataIntegrity Full time ₹ 18,00,000 - ₹ 25,00,000

Job Summary:

The Central Data Integrity Specialist II plays a key role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical analysis, and proactive risk management.

This position involves leading the development of Quality Management plans, conducting study risk assessments, identifying study Key Risk Indicators (KRIs), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly Quality meetings.

The Central Data Integrity Specialist II works independently and manages report review and issue escalation for more complex studies and/or portfolios of work.

Further, this role 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.
  • Quality Meetings: Support monthly Quality 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.
Qualifications:
  • Bachelor's Degree: In a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience.
  • Minimum Experience: 2 years' experience in clinical monitoring, clinical trial management, or equivalent.
  • Working Knowledge: ICH GCP guidelines and the clinical development process.
Skills:
  • Statistical Analysis: And data monitoring.
  • Risk Assessment: And mitigation.
  • Report Writing: And presentation.
  • Collaboration: And teamwork.

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