Senior Study Start-up Manager

Beonemedicines Com Br

Sao Paulo, Brazil
Hybrid
Study start-up delivery
Ich/gcp compliance
Local regulations adherence
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.
  • Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out.

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

  • Study Start-up delivery
  • ICH/GCP compliance
  • Local regulations adherence
  • Central IRB set-up
  • SSU process improvement
  • Clinical trial submissions

Nice-to-have

  • Scientific and business professionals
  • Collaborative and passionate interest
  • Spanish language proficiency
  • Therapeutic area knowledge
  • Site partnership data leverage

Key Requirements

  • Minimum 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

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