Senior Central Monitor

As a Senior Central Monitor, you will play a crucial role in maintaining the quality and integrity of clinical trial data by conducting centralized monitoring activities, statistical data review, and proactive risk management. Your responsibilities will include: - Leading the development of Risk-Based Quality Management (RBQM) plans by collaborating with cross-functional teams to design tailored plans for each study, including identification of critical data, definition of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs), and implementing centralized monitoring approaches. - Conducting thorough risk assessments for clinical studies, identifying potential issues, and developing mitigation strategies in consultation with functional team leads and project managers. - Performing centralized statistical monitoring and data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance. - Facilitating monthly RBQM meetings by supporting the review of study data, documenting findings, action plans, and coordinating data cleaning activities to support study deliverables. - Ensuring the highest standards of data quality and integrity through proactive monitoring and timely interventions. - Collaborating closely with clinical operations, data management, biostatistics, and other departments to provide proactive oversight and support for data cleaning in studies. - Mentoring and supporting junior colleagues by sharing best practices and lessons learned to enhance team performance. - Supporting discussions with sponsors on risk management and proactive data cleaning. Qualifications required for this role include: 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 of experience in clinical monitoring, clinical trial management, or equivalent. - Working knowledge of ICH Good Clinical Practice (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. - Proficiency in statistical analysis and data monitoring tools. - Detail-oriented with strong analytical and problem-solving skills. - Demonstrated experience with integrated risk planning and management. - Ability to mentor junior team members. Preferred: - CRO experience as a Central Monitor. Key skills for this role include: - 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 our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.,