Associate/clinical Project Manager, Sponsor Dedicated

IQVIA

Seoul, South Korea
Operational oversight of assigned protocol
Ensure quality data and compliance
Drive study compliance and analysis
Services include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities

Job Summary

  • Services include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities.
  • Partners with the Clinical Trial Assistant (CTA)/Investigator Document Assistant (IDA), Clinical Research Associate (CRA) and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery at the country level.
  • Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements.

Matching Summary

Services include operational oversight of assigned protocol(s) at the country level from start-up through to database lock and closeout activities.

Skills & Requirements

Must-have

  • Operational oversight of assigned protocol
  • Ensure quality data and compliance
  • Drive study compliance and analysis
  • Patient safety and AE/SAE reporting
  • Inspection readiness and document maintenance
  • Local regulatory requirements adherence

Nice-to-have

  • Contribute to quality site selection
  • Develop local trial specific procedures
  • Partner with functional areas
  • Therapeutic area knowledge development

Key Requirements

  • 2 years local trial management experience
  • BA/BS degree in health or science
  • Strong ICH-GCP knowledge
  • Proficient in country language and English

Work Rights

Not specified

Tailored Resume

Cover Letter