Director Centralized Clinical Monitoring
Clinical ResearchOther Advanced RequiredExecutive Director
About the role
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 proposals and client engagement.
- Proven experience leading global, multidisciplinary teams and complex clinical portfolios.
About Novotech
Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory company that provides biotech and small- to mid-sized pharma companies an accelerated path to market since 1997. With a global footprint spanning 30+ offices across the Asia-Pacific region, North America, and Europe, and partnerships with 5,000+ trial sites, Novotech offers unparalleled access to key clinical trial destinations and diverse patient populations. Novotech leverages its therapeutic and regulatory expertise, client-centric service model, local market insights, and advanced analytical tools to expedite patient recruitment, enhance trial efficiencies, and bring life-changing therapies to market faster. This work has been recognized by awards such as the Frost & Sullivan CRO Company of the Year, which Novotech has received for 19 consecutive years. For more information or to speak to an expert team member visit www.Novotech-CRO.com