Job Description

Position Summary:

The Senior Central Monitor will play a key role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. This position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study KRIs (in collaboration with Functional leads), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings. works independently and manages report review and issue escalation for more complex studies and/or portfolios of work. Further, the Central Monitor may mentor junior colleagues, and may support the development of processes, procedures and other documentation to ensure a high functioning team

Essential functions of the job include but are not limited to:

Lead Development of RBQM Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's specific needs - including identification of critical data & process, definition of KRIs & QTLs and centralized monitoring approach 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: lead facilitation of 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 Mentor and Support Junior Colleagues: Act as a mentor to more junior Central Monitors - sharing best practices, lessons learned, etc. to improve team performance Sponsor Engagement and Communications: support discussions with Sponsors around risk management and proactive data cleaning

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 5 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 Demonstrated experience with integrated risk planning & management Ability to mentor junior team members

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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