Senior Clinical Operations Specialist

2 days ago


Pune, Maharashtra, India beBeeClinical Full time ₹ 90,00,000 - ₹ 1,20,00,000
Job Overview

The Central Monitor II 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.

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


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