Central Monitoring Specialist

8 hours ago

Kolkata, West Bengal, India beBeeRisk Full time ₹ 18,54,816 - ₹ 28,12,128

**Central Monitoring Specialist Role Overview

As a Central Monitor, you will play a vital role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities. This involves leading the development of Risk-Based Quality Management plans, conducting study risk assessments, identifying potential issues, and implementing mitigation strategies.

Key Responsibilities:

  • Develop and execute Risk-Based Quality Management plans to ensure data quality and integrity.
  • Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
  • Perform centralized statistical monitoring and data analysis to detect anomalies and trends.
  • Support monthly RBQM meetings by reviewing study data, documenting findings, and coordinating data cleaning activities.
  • Collaborate with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management.
  • Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.

Requirements:

  • Bachelor's degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant combination of education, training, and experience.
  • Minimum 2 years of experience in clinical monitoring, clinical trial management, or equivalent.
  • Working knowledge of ICH GCP guidelines and the clinical development process.
  • Excellent written and spoken English communication skills, including strong grammar and scientific vocabulary skills.
  • Ability to work independently and as part of a team.

Preferred Qualifications:

  • CRO experience as a Central Monitor.
  • Statistical analysis and data monitoring skills.
  • Risk assessment and mitigation skills.
  • Report writing and presentation skills.

What We Offer:

A dynamic work environment with opportunities for professional growth and development. A competitive salary and benefits package. The chance to make a meaningful contribution to the success of our organization.

How to Apply:

If you are a motivated and detail-oriented individual with a passion for central monitoring, we encourage you to apply for this exciting opportunity.

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