Senior Study Start-up Manager

BeOne

Sao Paulo, Brazil
Not specified; not specified; not specified
Hybrid
Fluent english language proficiency
7 years clinical research experience
Ich/gcp and local regulation knowledge
The role is accountable for delivering study start-up activities within established timelines while ensuring high quality and compliance with ICH/GCP and local regulations

Job Summary

  • The role is accountable for delivering study start-up activities within established timelines while ensuring high quality and compliance with ICH/GCP and local regulations.
  • Candidates must have a minimum of 7 years of progressive experience in clinical operations within the biotech or pharmaceutical sector.
  • This position offers a hybrid work model requiring 2 to 3 days per week in the Sao Paulo office.

Matching Summary

The role is accountable for delivering study start-up activities within established timelines while ensuring high quality and compliance with ICH/GCP and local regulations.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • Fluent English language proficiency
  • 7 years clinical research experience
  • ICH/GCP and local regulation knowledge
  • Site feasibility and activation expertise
  • Central IRB set-up and close-out
  • SSU metrics and KPI monitoring

Nice-to-have

  • Spanish language skills
  • Hematology and Oncology therapeutic area
  • Process improvement and best practices
  • Collaborative spirit and teamwork
  • Passionate interest in fighting cancer

Key Requirements

  • Bachelor's degree in scientific or healthcare discipline
  • Minimum 7 years progressive clinical research experience
  • Line management and supervisory experience required
  • Functional Service Provider (FSP) model knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter