Director Centralized Clinical Monitoring

Novotech; Raleigh (NC); On-site; USD 170,000 - 200,000; Full time

Job summary

Novotech is seeking a Director Centralized Clinical Monitoring in Raleigh, North Carolina. This senior leadership role will oversee Risk-Based Quality Management and centralized monitoring capabilities, ensuring high-quality clinical trials through strategic design and operational oversight.

The successful candidate will possess a deep understanding of RBQM methodologies and extensive experience in the pharmaceutical or biotechnology sectors. The salary band ranges from $170,000 to $200,000 based on experience.

Qualifications

• 15+ years of experience in pharmaceutical, biotechnology, or CRO environments.
• Minimum 7 years of senior management experience in centralized monitoring or clinical operations.
• Deep expertise in RBQM methodologies and ICH E6/E8 principles.

Responsibilities

• Provide strategic and operational leadership for global RBQM and centralized monitoring frameworks.
• Lead the development and execution of risk assessments and monitoring strategies.
• Oversee resource planning, budgeting, and performance management for centralized monitoring teams.

Skills

Leadership

Strategic Planning

Risk-Based Quality Management (RBQM)

Data-driven Insights

Clinical Operations

Education

Advanced degree in life sciences or related discipline

Job description

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.

Salary Band – Director Centralized Clinical Monitoring $170,000 to $200,000 USD – Salary offered will be based on candidate’s experience level.

Find out more about working at Novotech at: www.novotech-cro.com/careers.

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability, or have caring responsibilities.