Senior Study Start-up Specialist

BeiGene

São Paulo, Brazil
Hybrid
Ich/gcp and local regulations
Site feasibility and engagement
Clinical trial document management
Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeiGene SOPs, and local regulations

Job Summary

  • Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeiGene SOPs, and local regulations.
  • Skilled in driving kick-off and completion of tasks from selection through activation, leveraging and building upon existing site partnership data to execute start-up efficiently.
  • Contribute to the ongoing improvement of SSU infrastructure in the Americas – in the U.S., Canada, and Latin America.

Matching Summary

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

Skills & Requirements

Must-have

  • ICH/GCP and local regulations
  • Site feasibility and engagement
  • Clinical trial document management
  • Central IRB submissions
  • CTMS data entry

Nice-to-have

  • Scientific and business professionals
  • Passionate interest in fighting cancer
  • Collaborative and highly motivated
  • Continuous learning and embraces change
  • Entrepreneurial mindset

Key Requirements

  • Minimum 3 years clinical research experience
  • Bachelor's degree or higher in scientific/healthcare
  • Fluent Portuguese and English required

Work Rights

Not specified

Tailored Resume

Cover Letter