Central Monitor II

Position:
Central Monitor II

Company:
Precision Medicine Group

Location:
India, Bangalore

Employment type:
Not Specified

Work Arrangement:
Hybrid (3 days weekly in office)

Short Summary:
The Central Monitor II will ensure the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. This role involves leading the development of Risk-Based Quality Management (RBQM) plans and conducting study risk assessments.

Responsibilities:
- Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
- Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks.
- Support monthly RBQM meetings by reviewing study data, documenting findings, and coordinating data cleaning activities.
- Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
- Work closely with clinical operations, data management, biostatistics, and other departments.
- Prepare detailed reports and presentations on monitoring activities, findings, and recommendations.
- Oversee operational study metrics and proactively communicate issues to study team members.

Requirement:
- Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or equivalent combination of education, training, and experience.
- Minimum 2 years experience in clinical monitoring, clinical trial management, or equivalent.
- Working knowledge of ICH GCP guidelines and the clinical development process.
- Highly effective oral and written communication skills.
- Excellent organizational and time management skills.
- Strong understanding of RBQM principles and methodologies.
- Proficiency in statistical analysis and data monitoring tools.

Benefits:
Not Specified