Senior Clinical Data Analyst

2 weeks ago

Thāne, Maharashtra, India beBeeClinical Full time US$ 1,00,000 - US$ 1,50,000
Job Overview

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

This position requires a high level of expertise in data analysis, risk management, and communication skills to effectively work with cross-functional teams.

Key Responsibilities:
  • Risk-Based Quality Management (RBQM) Planning: Develops RBQM plans and conducts study risk assessments to identify potential issues and develop mitigation strategies.
  • Data Analysis and Monitoring: Performs centralized statistical monitoring and data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
  • Study Support: Supports monthly RBQM meetings by reviewing study data, documenting findings, and coordinating data cleaning activities to support study deliverables.
  • Data Integrity: Ensures the highest standards of data quality and integrity through proactive monitoring and timely interventions.
  • Collaboration: Collaborates closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.
  • Reporting: Prepares detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
Qualifications:
  • Educational Background: Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience.
  • Professional Experience: Minimum 2 years experience in clinical monitoring, clinical trial management, or equivalent.
  • Knowledge and Skills: Working knowledge of ICH GCP guidelines and the clinical development process.

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