Ctm Ii

Syneos Health

Client, ,
On-site
Patient safety and data integrity
Gcp and regulatory compliance
Risk assessment and mitigation
Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity

Job Summary

  • Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
  • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks.
  • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.

Matching Summary

Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.

Skills & Requirements

Must-have

  • Patient safety and data integrity
  • GCP and regulatory compliance
  • Risk assessment and mitigation
  • Clinical monitoring deliverables
  • Site management oversight

Nice-to-have

  • Agile and driven to deliver
  • Collaborative problem solving
  • Inclusive and authentic culture

Key Requirements

  • Bachelor's degree or RN
  • Demonstrated leadership skills
  • International environment experience
  • Risk-based monitoring experience
  • GCP/ICH Guidelines knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter