Senior Central Monitor

Job Description

Precision Medicine Group is seeking a Senior Central Monitor to ensure the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. The Senior Central Monitor 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. The role involves independent work and managing report review and issue escalation for complex studies. The Central Monitor may also mentor junior colleagues and support the development of processes and procedures.Responsibilities:

• Lead the development of RBQM plans tailored to each study's specific needs.
• Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
• Perform centralized statistical monitoring and data analysis to detect anomalies, trends, and potential risks.
• Lead facilitation of monthly RBQM meetings, supporting review of study data and documenting findings.
• Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
• Collaborate with clinical operations, data management, biostatistics, and other departments.
• Prepare detailed reports and presentations on monitoring activities and findings.
• Oversee operational study metrics and proactively communicate issues to study team members.
• Mentor junior Central Monitors, sharing best practices and lessons learned.
• Support discussions with Sponsors around risk management and proactive data cleaning.

Requirements:

• Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations).
• Minimum 5 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 and electronic study data systems.
• Proficiency in statistical analysis and data monitoring tools.
• Detail-oriented with strong analytical and problem-solving skills.
• Demonstrated experience with integrated risk planning & management.
• Ability to mentor junior team members.

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.
• Opportunity to mentor junior colleagues.