Central Monitor II

As a Central Monitor II at Precision Medicine Group, you will be responsible for ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. Your role will involve leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study Key Risk Indicators (KRIs) in collaboration with Functional leads, performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings. Additionally, you will work independently, manage report review, and escalate issues for more complex studies or portfolios of work. You may also have the opportunity to mentor junior colleagues and support the development of processes, procedures, and documentation to ensure a high-functioning team. 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 on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance. - Support monthly RBQM meetings by reviewing study data, documenting findings, creating action plans, and coordinating data cleaning activities to support study deliverables. - Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions. - Collaborate closely with clinical operations, data management, biostatistics, and other departments to provide proactive oversight and management of data cleaning for studies. - 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, site health trending, and proactively communicate issues to study team members to drive towards resolution and 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 of 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. Please note that any data provided as a part of this application will be stored in accordance with the company's Privacy Policy. For California applicants, please also refer to the CA Privacy Notice. If you require a reasonable accommodation to complete any part of the application process or need an alternative method for applying due to a disability, please contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It is important to be cautious of fraudulent job offers. Precision Medicine Group emphasizes that job offers are only extended after prior communication with the recruiting team, hiring managers, and a formal interview process.,