Senior Study Start-up Manager

beonemedicines.nl

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.
  • Demonstrates mastery of skills required to conduct SSU and maintenance activities, providing country-specific SSU expertise to project teams.

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
  • SSU metrics monitoring
  • Process improvement
  • Central IRB setup
  • Document management and negotiation

Nice-to-have

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

Key Requirements

  • Minimum 7 years progressive experience
  • Clinical research and operations experience
  • Biotech, pharmaceutical, or CRO environment
  • Knowledge of ICH/GCP
  • Line management experience
  • Functional Service Provider model knowledge

Work Rights

Not specified

Tailored Resume

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