Director, Process, Standards And Signal Interpretation Lead

CSL Ltd

Multiple Locations
Fully remote
10 years site monitoring experience
Risk-based monitoring strategies
Gcp and regulatory operations knowledge
CSL Ltd is seeking a Director, Process, Standards, and Signal Interpretation Lead to oversee and improve processes related to site monitoring and engagement in clinical trials. The ideal candidate will have extensive experience in global clinical trials, strong analytical skills, and a focus on continuous improvement in clinical practices

Job Summary

  • The role supports enterprise-level processes for start-up, site monitoring, and oversight while identifying innovative continuous improvement opportunities.
  • This position is responsible for developing KPIs, monitoring performance trends, and collaborating with Clinical Compliance to resolve issues and ensure adherence to compliance plans.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies and advanced technologies.

Matching Summary

Match Score: 85

CSL Ltd is seeking a Director, Process, Standards, and Signal Interpretation Lead to oversee and improve processes related to site monitoring and engagement in clinical trials. The ideal candidate will have extensive experience in global clinical trials, strong analytical skills, and a focus on continuous improvement in clinical practices.

Skills & Requirements

Must-have

  • 10 years site monitoring experience
  • Risk-based monitoring strategies
  • GCP and regulatory operations knowledge
  • Data trend analysis and KPI development
  • CRO partner oversight and collaboration

Nice-to-have

  • AI innovation in study start-up
  • Strategic thinking and problem solving
  • Cross-functional team leadership
  • Continuous improvement methodologies
  • Experience with harmonized global processes

Key Requirements

  • Minimum 10 years in site or central monitoring process development
  • Extensive experience in global clinical trials
  • Strong understanding of Good Clinical Practices (GCPs)

Work Rights

Not specified

Tailored Resume

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