Director Centralized Clinical Monitoring
$170k - $200kNovotech Global
About the Role The Director Centralized Clinical Monitoring is a senior leadership role responsible for the strategic and operational oversight of Risk-Based Quality Management (RBQM) and centralized monitoring capabilities. This role leads the design, delivery, and continuous improvement of centralized monitoring strategies to ensure high-quality, inspection-ready clinical trials, leveraging data-driven insights across global clinical programs. Responsibilities * Provide strategic and operational leadership for global RBQM and centralized monitoring frameworks. * Serve as a subject matter expert for RBQM methodologies, tools, and centralized monitoring practices. * Lead the development and execution of risk assessments, monitoring strategies, and mitigation plans for critical data and processes. * Ensure consistent, high-quality delivery of centralized monitoring outputs across studies and programs. * Partner with Clinical Operations, Data Management, Biostatistics, Quality, and Technology teams to drive integrated data surveillance. * Develop and implement policies, standards, and best practices for centralized clinical monitoring. * Oversee resource planning, budgeting, and performance management for centralized monitoring teams. * Mentor, develop, and lead senior managers and subject matter experts within the RBQM function. * Act as an executive-level advisor to internal stakeholders and clients on RBQM and monitoring strategy. * Line Management to 10+ direct reports. Experience and Qualifications * Advanced degree in life sciences, clinical research, pharmacy, or a related discipline. * 15+ years of experience in pharmaceutical, biotechnology, or CRO environments. * Minimum 7 years of senior management experience in centralized monitoring, RBQM, or clinical operations leadership.
- Deep expertise in RBQM methodologies and ICH E6/E8 principles.
- Support business development activities by contributing RBQM expertise to
- Strategic vs transactional mindset.
- Ability to gain insights and make proactive decisions quickly.
- Culture that fosters partnership and collaboration, where every voice is
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