Central Monitor II

Job Description

Precision Medicine Group is seeking a Central Monitor II to ensure the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. The Central Monitor II will lead the development of Risk-Based Quality Management (RBQM) plans, conduct study risk assessments, identify study KRIs, perform ongoing centralized statistical monitoring, remote centralized data review, and facilitate monthly RBQM meetings. This role involves independent work and managing report review and issue escalation for complex studies.Responsibilities:

• Conduct thorough risk assessments for clinical studies.
• Perform centralized statistical monitoring & data analysis on study data.
• Support monthly RBQM meetings by supporting review of study data.
• Ensure the highest standards of data quality and integrity.
• Work closely with clinical operations, data management, biostatistics, and other departments.
• Prepare detailed reports and presentations on monitoring activities.
• Oversee operational study metrics and proactively communicate issues to study team members.

Requirements:

• Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations).
• 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.
• Excellent written and spoken English, including strong grammar and scientific vocabulary skills.
• Strong understanding of RBQM principles and methodologies.
• Demonstrated ability to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk.
• Proficiency in statistical analysis and data monitoring tools.
• Detail-oriented with strong analytical and problem-solving skills.

The role offers:

• Opportunity to play a key role in ensuring the quality and integrity of clinical trial data.
• Chance to lead the development of Risk-Based Quality Management (RBQM) plans.
• Collaborative work environment with clinical operations, data management, and biostatistics departments.