Clinical Trial Management Lead

Job Summary

A company is looking for a Clinical Trial Management PV Lead.

Key Responsibilities

• Oversee safety operational processes and strategic content for clinical studies
• Develop training materials for clinical trial safety data reporting and collection
• Lead quality reviews of Individual Case Safety Reports (ICSRs) and manage data quality KPIs

Required Qualifications

• Bachelor's degree in a biological or natural science, or health care discipline
• Eight (8)+ years of pharmacovigilance and GCP experience
• Extensive experience in case processing and handling of ICSRs
• Proficient in Argus and understanding of global safety reporting regulations
• Strong analytic and organizational skills with project management capabilities