Clinical Site and Monitoring Health Lead in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Clinical Site and Monitoring Health Lead in the United States.

This role is focused on ensuring the quality, consistency, and regulatory compliance of clinical trial execution at investigator sites through robust monitoring oversight and risk-based quality management. You will act as a key guardian of site performance, ensuring that CRO monitoring activities meet expectations and that studies remain inspection-ready at all times. The position combines hands-on oversight, risk analysis, and cross-functional collaboration to identify issues early and implement corrective strategies that improve study quality and patient safety. You will work closely with study teams, CROs, and investigator sites to strengthen operational delivery and ensure alignment with global regulatory standards. This is a highly visible, site-facing role requiring strong judgment, analytical capability, and proactive problem-solving. It offers the opportunity to directly influence the quality and integrity of clinical research across multiple studies and regions.

• Oversee monitoring effectiveness across assigned clinical studies, ensuring high-quality execution and compliance with GCP and regulatory standards.
• Conduct and coordinate oversight activities including site risk assessments, monitoring visit reviews, data evaluations, and sponsor oversight visits.
• Perform aggregate data reviews and system spot checks to ensure study-level and site-level quality oversight.
• Develop and maintain Study Specific Oversight Plans (SSOPs) and ensure alignment with risk management frameworks.
• Apply risk-based approaches to identify critical quality issues and ensure appropriate mitigation strategies are implemented.
• Perform root cause analysis of identified issues and provide actionable recommendations to CROs and study teams.
• Support inspection readiness activities and contribute to regulatory inspection preparation and management.
• Lead oversight meetings with study teams and CROs to review risks, trends, and performance metrics.
• Build and maintain strong relationships with investigator sites to support engagement, performance, and recruitment success.
• Serve as a resource for site staff, particularly less experienced research sites, to enhance operational readiness.
• Collaborate with Clinical Risk and Analytics teams to ensure alignment with study risk management plans.
• Stay current with global and regional regulatory requirements and ensure consistent application across studies.

• Significant experience in clinical monitoring within a CRO or pharmaceutical environment, supporting multinational clinical trials.
• Prior Lead CRA experience is required.
• Strong background in clinical study oversight, including CRO monitoring oversight and sponsor-facing responsibilities.
• Experience across Phase I–III clinical trials.
• Knowledge of GCP, ICH guidelines, and global regulatory frameworks.
• Previous involvement in audit and/or regulatory inspection preparation is highly preferred.
• Strong analytical and problem-solving skills with the ability to assess complex clinical quality issues.
• Excellent communication skills, with the ability to influence stakeholders and present recommendations clearly.
• Strong relationship-building skills with investigators, site staff, and cross-functional teams.
• Proficiency in MS Office (Excel, Word, PowerPoint) and ability to learn clinical systems quickly.
• Ability to travel moderately within assigned regions as required.
• Strong organizational skills with the ability to manage multiple priorities in a dynamic environment.

• Competitive compensation package aligned with experience and expertise.
• Opportunity to work on global, multi-phase clinical trials with high scientific impact.
• Exposure to advanced risk-based monitoring and quality oversight frameworks.
• Collaborative environment working with leading CROs, investigators, and clinical experts.
• Strong focus on professional growth, regulatory expertise, and leadership development.
• Opportunity to influence clinical quality and inspection readiness across multiple studies.
• Flexible, travel-based role with regional engagement opportunities.