Clinical Site and Monitoring Health Lead

USFull-TimeLead

Salary not disclosed

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Job Details

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.
Proficiency in MS Office (Excel, Word, PowerPoint) and ability to learn clinical systems quickly.

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.

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