Central Monitor II

• Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and PM
• Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
• RBQM Meetings: support monthly RBQM meetings by supporting review of study data, documenting findings, action plans and coordination of data cleaning activities to support study deliverables
• Data Quality Assurance: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
• Collaboration: Work closely with clinical operations, data management, biostatistics, and other departments to support proactive oversight and management and data cleaning for studies
• Reporting: Prepare detailed reports and presentations on monitoring activities, findings, and recommendations for sponsors and study teams.
• Operational Insights: Oversee operational study metrics, including data entry trends, SDV backlog, site health trending and proactively communicate issues to study team members to drive towards resolution & proactive remediation

Qualifications:

Minimum Required:

• Bachelor’s Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/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

Other Required:

• Highly effective oral and written communication skills with the ability to communicate effectively with project team members
• Excellent organizational and time management skills
• Excellent written and spoken English, including strong grammar and scientific vocabulary skills
• Ability to work in a team or independently as required
• Strong understanding of RBQM principles and methodologies.
• Demonstrated ability to learn how 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

Preferred:

• CRO experience as a Central Monitor

Skills:

• Statistical analysis and data monitoring
• Risk assessment and mitigation
• Report writing and presentation
• Collaboration and teamwork

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