Senior Data Integrity Specialist

At Precision Medicine Group, we are seeking a highly skilled Central Monitor to join our team. As a key member of our clinical operations group, the Central Monitor will play a critical role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.

Risk-Based Quality Management (RBQM)

The Central Monitor will lead the development of RBQM plans, conduct study risk assessments, identify study KRIs, and perform ongoing centralized statistical monitoring. They will also facilitate monthly RBQM meetings and work closely with functional teams to ensure data accuracy and compliance.

In addition, the Central Monitor may mentor junior colleagues and support the development of processes, procedures, and documentation to ensure a high-functioning team. This is an exciting opportunity for a detail-oriented individual with strong analytical and problem-solving skills to join our team and contribute to the success of our clinical trials.

Key Responsibilities :

• Study Risk Assessment : Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies
• Centralized Statistical Monitoring : Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks
• RBQM Meetings : Support monthly RBQM meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities
• 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

Requirements :

To be successful as a Central Monitor, you should have :

Preferred Qualifications :

We also welcome applicants with :

Precision Medicine Group is an Equal Opportunity Employer and welcomes applications from diverse candidates. If you are interested in this exciting opportunity, please submit your application.