Director, Site Engagement & Monitoring Excellence (CONTRACT)
About The Position
The Director, Study Site Engagement & Monitoring Excellence (Contract) leads the development and execution of Eikon’s global trial site engagement strategy and oversees internal and externally managed site monitoring activities. The role is accountable for predictable delivery of high-quality data, effective site relationships, and positioning Eikon as a preferred sponsor for clinical sites. The Director collaborates with clinical study teams and Functional Service Provider (FSP) partners to support site relationship management and monitoring across Eikon’s clinical programs. The position requires onsite presence at least three days per week, or more as business needs require, at either the California or New Jersey office. The Director provides strategic and operational leadership to the site engagement team, including CRA monitors and FSP partners; establishes performance standards and harmonized processes; oversees resources, talent, budgets, quality, and training; and ensures compliance with ICH GCP and applicable global and regional regulatory requirements. The role uses site intelligence, metrics, and risk-based monitoring signals to identify and mitigate risks, resolve escalations, and improve study delivery. It also contributes to department infrastructure and process development, collaborates with Clinical Development leadership, and develops and retains team talent. Travel of up to 25% is expected.
Requirements
- Postgraduate degree and 10 or more years of relevant experience, or a bachelor’s degree and 12 or more years of relevant experience.
- Relevant experience in Life Sciences, Nursing, or a related discipline.
- Significant management experience in an oncology clinical trial setting.
- Ability to collaborate effectively with Clinical R&D stakeholders in a matrix organization.
- Management expertise covering budgets, resources, headcount, processes and controls, productivity, quality, and project delivery.
- Complete understanding of ICH GCP and global and regional regulatory requirements.
- Strong written and spoken English communication skills.
- Strategic thinking and high emotional intelligence.
- Leadership skills to attract, motivate, inspire, develop, and retain talented staff and align teams with company goals, purpose, and mission.
Nice To Haves
- Proficiency in more than one language.
- Competence with metrics and performance standards (KPIs).
Responsibilities
- Define and implement site engagement strategies to improve relationships with clinical trial sites.
- Support the development of new partnerships and networks.
- Support high-quality monitoring approaches and ensure alignment with regulatory standards.
- Serve as a liaison between clinical study teams and investigative sites.
- Provide guidance, oversight, and training to the study site engagement team, including CRA site monitors and insourced or outsourced suppliers.
- Develop and maintain performance standards, processes, and documentation for harmonized site engagement and monitoring across clinical programs.
- Maintain information exchange within the team, identify common study-support needs across regions and countries, apply lessons learned, troubleshoot issues, and distribute site intelligence to relevant Clinical Operations and Clinical Development stakeholders.
- Oversee resource and talent management for the site engagement team and CRA monitors across regional and country clusters.
- Oversee and train FSPs, site engagement staff, and CRAs by country and region; identify and manage CRA performance issues and ensure corrective and preventive actions are implemented.
- Ensure ICH GCP compliance and achievement of regulatory, quality, and timeline objectives for globally executed trials.
- Oversee site and monitoring quality using interpretive signals and local intelligence to identify risks proactively.
- Lead site- and country-level risk assessments for designated studies and identify mitigation and controls.
- Use metrics, site health information, and risk-based monitoring signals to improve quality and accelerate study delivery; track site engagement metrics and satisfaction scores.
- Share site quality trends and preventive actions across studies and clinical programs.
- Act as the escalation point for site engagement issues, keep relevant study teams informed, and resolve issues using sound judgment regarding regulations, investigator interactions, and timelines.
- Manage the functional budget, resource projections, capacity assessment, and vendor oversight and evaluation.
- Align with global Clinical Development stakeholders on strategies and approaches that meet study goals and incorporate input from the site engagement team and CRA monitors.
- Contribute to department infrastructure development, including SOP development and implementation and innovation in processes and clinical system capabilities.
- Collaborate with Clinical Development leadership on important projects and relevant industry trends and innovations.
- Develop, coach, and retain team talent; establish clear performance standards; and use KPIs and other metrics to support accountability and results.
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What This Job Offers
Career Level
Director
