Clinical Site And Monitoring Health Lead

TL;DR

Clinical Site and Monitoring Health Lead (Medical): Overseeing clinical trial quality and regulatory compliance at investigator sites with an accent on risk-based monitoring and sponsor oversight. Focus on ensuring inspection readiness, managing CRO performance, and implementing corrective strategies to maintain data integrity and patient safety.

Location: Must be based in the United States

Company

hirify.global is an AI-powered recruitment platform connecting candidates with global opportunities.

What you will do

• Oversee monitoring effectiveness across clinical studies to ensure compliance with GCP and regulatory standards.
• Conduct site risk assessments, review monitoring visits, and perform aggregate data evaluations.
• Develop and maintain Study Specific Oversight Plans (SSOPs) aligned with risk management frameworks.
• Lead oversight meetings with study teams and CROs to track performance metrics and mitigate risks.
• Perform root cause analysis of quality issues and implement effective corrective strategies.
• Support inspection readiness activities and contribute to regulatory inspection preparation.

Requirements

• Must be based in the United States
• Significant experience in clinical monitoring within a CRO or pharmaceutical environment.
• Prior Lead CRA experience is required.
• Experience across Phase I–III clinical trials.
• Strong knowledge of GCP, ICH guidelines, and global regulatory frameworks.
• Ability to travel moderately within assigned regions as required.

Nice to have

• Previous involvement in audit and/or regulatory inspection preparation.

Culture & Benefits

• Competitive compensation package.
• Opportunity to work on global, multi-phase clinical trials.
• Exposure to advanced risk-based monitoring and quality oversight frameworks.
• Collaborative environment with leading clinical experts.
• Strong focus on professional growth and leadership development.