Study Start-up Specialist

beigene.se

Sao Paulo, Brazil
Hybrid
Ich/gcp and local regulations
Site feasibility and start-up
Submission dossier preparation
Support in 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

  • Support in 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.
  • 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.
  • Prepare submissions dossiers to Ethics Committees and Regulatory Authorities according to applicable regulations, SOPs and work instructions.

Matching Summary

Support in 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

  • ICH/GCP and local regulations
  • Site feasibility and start-up
  • Submission dossier preparation
  • Project timeline management
  • Document management and negotiation
  • Central IRB submissions

Nice-to-have

  • Collaborative and passionate interest
  • Scientific and business professionals
  • Streamline output and deliverables
  • Ongoing improvement of SSU infrastructure

Key Requirements

  • Minimum 2 years progressive experience
  • Bachelor's degree or higher
  • Experience in clinical research operations
  • Fluent English required

Work Rights

Not specified

Tailored Resume

Cover Letter