Study Start-up Head, Latam

BeOne

Sao Paulo, Brazil
Hybrid
8+ years clinical research experience
6+ years study start-up in latin america
Fluent english language proficiency
The role is responsible for the identification, selection, activation, and maintenance of clinical sites for large global oncology trials in Phase I-IV across Latin America

Job Summary

  • The role is responsible for the identification, selection, activation, and maintenance of clinical sites for large global oncology trials in Phase I-IV across Latin America.
  • Candidates must demonstrate mastery of study start-up activities from selection through activation while ensuring compliance with country-specific regulations and ethics committees.
  • The position requires leading a team in Brazil and LATAM, managing Functional Service Providers, and driving operational improvements to optimize efficiencies within the region.

Matching Summary

The role is responsible for the identification, selection, activation, and maintenance of clinical sites for large global oncology trials in Phase I-IV across Latin America.

Skills & Requirements

Must-have

  • 8+ years clinical research experience
  • 6+ years Study Start-up in Latin America
  • Fluent English language proficiency
  • Oversight of CROs and vendors
  • Knowledge of FDA GCP ICH guidelines

Nice-to-have

  • Spanish language skills
  • Hematology or Oncology therapeutic knowledge
  • Regulatory authority inspection experience
  • Functional Service Provider model experience
  • Line management of direct reports

Key Requirements

  • Bachelor's degree in scientific or healthcare discipline
  • Masters degree preferred
  • Minimum 8 years clinical research experience
  • Minimum 6 years SSU and regulatory experience in Latin America
  • Documented training in FDA Regulations and GCP

Work Rights

Not specified

Tailored Resume

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