Senior Clinical Monitor

22 hours ago

Thiruvananthapuram, Kerala, India beBeeData Full time ₹ 13,20,593 - ₹ 18,68,224
Central Monitoring Specialist

The Central Monitoring Specialist 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
  • Risk-Based Quality Management (RBQM) Planning: Lead the development of RBQM plans to ensure the highest standards of data quality and integrity.
  • Clinical Study Risk Assessments: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies in consultation with functional team leads and project managers.
  • Statistical Monitoring & Data Analysis: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
  • Scheduling & Facilitating Meetings: Schedule and facilitate monthly RBQM meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities to support study deliverables.
Collaboration & Communication
  • Interdepartmental Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies.
  • Reporting & Presentations: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
  • Operational Study Metrics: 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 & Skills
  • Education: Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or equivalent combination of education, training, and experience.
  • Experience: Minimum 2 years of experience in clinical monitoring, clinical trial management, or equivalent.
  • ICH GCP Guidelines: Working knowledge of ICH GCP guidelines and the clinical development process.
Benefits & Opportunities
  • Professional Growth: Opportunities for professional growth and development in a dynamic and fast-paced environment.
  • Team Collaboration: Collaborate with experienced professionals in a supportive team environment.
  • Continuous Learning: Stay up-to-date with the latest industry developments and best practices through ongoing training and education.
About the Role

This is an excellent opportunity for a skilled Central Monitoring Specialist to join our organization and contribute to the success of our clinical trials. If you are a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply.

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