Senior Study Start-up Manager

BeOne Medicines Ltd

São Paulo, Brazil
Hybrid
Ich/gcp and local regulations
Study start-up delivery
Submission management
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.
  • Actively drives best practices and process improvement to effectively achieve SSU goals and optimize efficiencies within the SSU Team as well as the within the greater Americas region.
  • BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals who share our passionate interest in fighting cancer.

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
  • Submission management
  • Process improvement
  • SSU infrastructure development
  • Central IRB set-up

Nice-to-have

  • Scientific and business professionals
  • Highly motivated and collaborative
  • Passionate interest in fighting cancer
  • Spanish language proficiency

Key Requirements

  • Minimum 7 years progressive experience
  • Bachelor's degree or higher
  • Clinical research and operations experience
  • Line management experience
  • Functional Service Provider model knowledge

Work Rights

Not specified

Tailored Resume

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