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Site Monitoring Lead

Meet
Ridgefield, CT Full Time
POSTED ON 1/19/2025
AVAILABLE BEFORE 4/20/2025

Our client is seeking an experienced Site Monitoring Lead to oversee clinical trial monitoring activities for an exciting new Chronic Kidney Disease trial. In this fully remote role, you will ensure quality and compliance across multiple trials, collaborating with cross-functional teams to deliver risk-based monitoring approaches and supporting site management activities.

Key Responsibilities :

  • Lead and monitor clinical trial activities for 5-8 trials across therapeutic areas, including oncology and chronic kidney disease .
  • Oversee and provide guidance to Clinical Research Associates (CRAs) to ensure high-quality monitoring deliverables.
  • Develop and deliver training for CRAs and Clinical Trial Managers (CTMs) on site monitoring processes.
  • Conduct site and monitoring oversight visits, ensuring compliance with ICH-GCP, regulatory requirements, and trial protocols.
  • Support inspection readiness and preparation for regulatory inspections at the site level.

Qualifications :

  • Bachelor’s degree in Health Sciences, Nursing, or related field.
  • Minimum 5 years of on-site monitoring experience or 8 years of relevant clinical trial experience in the pharmaceutical or healthcare industry.
  • Proven expertise in large clinical trials, with a focus on oncology or chronic kidney disease .
  • Strong skills in risk assessment, CAPA, and project management.
  • This is a fantastic opportunity to make a meaningful impact in advancing therapies for chronic kidney disease while working in a dynamic, fully remote environment.

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