Director, Clinical Site & Monitoring Operations

Overview

This position provides senior leadership over global strategies that elevate clinical trial site engagement and monitoring quality. The Director will develop forward‑thinking approaches to strengthen site relationships, guide the oversight of monitoring activities, and reinforce the organization's standing as a dependable and collaborative study sponsor. A deep passion for patients and a commitment to improving their clinical experience is essential, as this role directly influences the quality, reliability, and integrity of studies that ultimately impact patient care.

Working closely with internal clinical teams and external operational partners, this role drives consistency, efficiency, and excellence in study‑site interactions worldwide. Regular in‑office presence is required to effectively support team development, operational alignment, and the delivery of high‑quality clinical programs.

• Build and execute a comprehensive framework for effective site engagement, fostering trust, transparency, and long‑term collaboration.
• Expand and strengthen networks that enhance regional and global site readiness and study execution.
• Promote monitoring methodologies aligned with international guidelines, regulatory expectations, and quality‑first principles.
• Ensure streamlined communication between clinical teams and study sites to support timely decision‑making and smooth trial progression.

• Lead and coach site‑engagement and monitoring staff, including in‑house CRAs and outsourced monitoring resources.
• Establish standardized processes, tools, and documentation that create unified monitoring practices across clinical programs.
• Drive cross‑regional learning through continuous sharing of insights, trends, and site feedback to improve operational performance.
• Oversee staffing plans, workload distribution, and capability development for regional monitoring personnel to maintain high performance and study quality.
• Manage oversight of external monitoring partners, ensuring performance expectations, training, and compliance obligations are consistently met.
• Use data‑driven indicators-such as quality metrics, RBM analytics, and performance dashboards-to anticipate issues, identify risks, and enhance delivery timelines.
• Serve as the primary escalation point for site‑related challenges and operational issues, ensuring resolution and communication with study leadership.
• Oversee budgeting, resource forecasting, and vendor management to ensure sufficient support for the expanding clinical trial portfolio.

• Work with clinical leadership to align site‑engagement and monitoring strategies with program needs and study objectives.
• Contribute to the development and refinement of SOPs, process improvements, clinical‑system enhancements, and other operational advancements.
• Stay current with emerging industry best practices to elevate site engagement approaches and enhance trial execution.
• Recruit, develop, and retain high‑performing team members; set clear expectations, promote accountability, and foster a culture of continuous growth.

• Advanced degree with 10+ years of relevant experience, or Bachelor's degree with 12+ years in Life Sciences, Nursing, or related discipline.
• Significant leadership experience in oncology trials and demonstrated effectiveness in cross‑functional, matrixed organizations.
• Deep working knowledge of ICH‑GCP, global regulatory requirements, and clinical operational standards.
• Strong written and verbal communication skills in English; additional languages are a plus.
• Demonstrated strengths in strategic thinking, emotional intelligence, and team development.
• Proven experience managing budgets, vendors, resources, quality metrics, and operational performance.
• Willingness to travel up to 25%.

This role offers a competitive salary range of $207,000-$229,000, plus bonus and equity opportunities, along with a comprehensive benefits package that includes:

• 401(k) with employer match
• Medical, dental, and vision coverage
• Mental health and wellness support
• Paid summer and winter holiday shutdowns