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.
Role involves: - Leading the development of RBQM plans
- Conducting study risk assessments
- Performing centralized statistical monitoring
- Facilitating monthly RBQM meetings
- Ensuring data quality assurance
- Preparing detailed reports
- Overseeing operational study metrics
- Mentoring junior colleagues
- Supporting discussions with Sponsors
Requirements: - Bachelor’s Degree in a relevant field
- Minimum 5 years experience in clinical monitoring or clinical trial management
- Working knowledge of ICH GCP guidelines
- Effective communication skills
- Excellent organizational and time management skills
- Strong understanding of RBQM principles
- Proficiency in statistical analysis and data monitoring tools
- Detail-oriented with strong analytical and problem-solving skills
- Demonstrated experience with integrated risk planning & management
Role offers: - Opportunity to lead and develop RBQM plans
- Chance to mentor junior colleagues
- Exposure to sponsor engagement and communications