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Precision Medicine Group seeks a Central Monitor II to ensure quality and integrity of clinical trial data through centralized monitoring, statistical analysis, and proactive risk management. This is a senior individual contributor role with mentoring responsibilities.
Key Responsibilities:
- Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies in consultation with functional team leads and project managers
- Perform centralized statistical monitoring and data analysis to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance
- Support monthly Risk-Based Quality Management (RBQM) meetings by reviewing study data, documenting findings, coordinating action plans, and supporting data cleaning activities
- Ensure highest standards of data quality and integrity through proactive monitoring and timely interventions
- Collaborate with clinical operations, data management, biostatistics, and other departments to support oversight and data cleaning
- Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams
- Oversee operational study metrics including data entry trends, SDV backlog, and site health trending; proactively communicate issues to drive resolution
- Mentor junior colleagues and support development of processes, procedures, and documentation
The role involves working independently on complex studies and portfolios, leading RBQM plan development, and identifying study Key Risk Indicators (KRIs) in collaboration with functional leads.
Requirements:
Minimum Required:
- Bachelor's degree in 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 clinical development process
Other Required:
- Highly effective oral and written communication skills
- Excellent organizational and time management skills
- Excellent written and spoken English with strong grammar and scientific vocabulary
- Ability to work independently or in a team as required
- Strong understanding of RBQM principles and methodologies
- Demonstrated ability to extract pertinent information from protocols, electronic study data systems, clinical systems, and dashboards to assess risk
- Proficiency in statistical analysis and data monitoring tools
- Detail-oriented with strong analytical and problem-solving skills
Preferred:
- CRO experience as a Central Monitor
