Senior Oncology Site Manager

1 semana atrás

São Paulo, São Paulo, Brasil beBeeOncology Tempo inteiro US$110.520 - US$138.150
Job Summary

The Senior Oncology Clinical Research Associate will be responsible for performing site management activities to support Oncology site success and maintain a continuous state of inspection readiness.

Key Responsibilities:
  • Conduct remote and on-site monitoring/co-monitoring visits to ensure data integrity and subject safety in trials.
  • Serve as the primary contact and facilitate efficient communications between the clinical trial team and the sites.
  • Maintain oversight activities to assess monitoring quality and train/mentor less experienced CRAs.
  • Timely document monitoring activities and submit/approve visit reports.
  • Manage site essential document collection and TMF reconciliation with site files.
  • Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals.
  • Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution.
  • Determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans.
  • Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations.
Requirements:
  • Bachelor's degree in a scientific field.
  • 5+ years of experience independently conducting on-site and remote monitoring visits in Oncology trials.
  • 1+ year of early development trial experience.
  • Prior experience in solid tumor clinical trials is preferred.
  • Experience utilizing Veeva systems is an asset.
  • Demonstrated ability to develop/maintain site relationships and secure compliance.
  • Expertise in GCPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology.
  • Ability to collaborate with sites from initial engagement through close-out phases.
  • Experience activating sites.
  • Experience training site staff.
  • Experience supporting sites and/or sponsors in regulatory inspections.
  • Experience working within an FSP (or in-house) monitoring model is preferred.

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