Senior Study Start-up Manager

beonemedicines.se

Sao Paulo, Brazil
Hybrid
Ich/gcp and local regulations
Study start-up delivery
Central irb set-up
Accountable for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne SOPs, and local regulations

Job Summary

  • Accountable for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne SOPs, and local regulations.
  • Gathers and monitors start-up metrics to measure against KPIs and actively drives best practices and process improvement to effectively achieve SSU goals.
  • Lead for central IRB set-up through close-out and key contact for SSU onboarding and process improvement in the Americas.

Matching Summary

Accountable for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne SOPs, and local regulations.

Skills & Requirements

Must-have

  • ICH/GCP and local regulations
  • Study start-up delivery
  • Central IRB set-up
  • Process improvement
  • Clinical trial execution

Nice-to-have

  • Collaborative and passionate interest
  • Scientific and business professionals
  • Proactive leadership
  • Best practices driving

Key Requirements

  • 7 years progressive experience
  • Bachelor's degree or higher
  • Pharmaceutical/Biotech/CRO experience
  • Line management experience
  • Functional Service Provider model knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter