Senior Study Start-up Manager

beonemedicines.sg

Sao Paulo, Brazil
Hybrid
7 years progressive clinical research experience
Ich/gcp and local regulatory compliance knowledge
Site feasibility and start-up execution skills
The role is accountable for delivering study start-up activities within established timelines while ensuring high quality and adherence to ICH/GCP standards

Job Summary

  • The role is accountable for delivering study start-up activities within established timelines while ensuring high quality and adherence to ICH/GCP standards.
  • Candidates must demonstrate mastery of SSU maintenance activities and provide country-specific expertise to project teams across the Americas region.
  • BeOne Medicines seeks professionals who share a passionate interest in fighting cancer and are motivated to optimize efficiencies within the SSU team.

Matching Summary

The role is accountable for delivering study start-up activities within established timelines while ensuring high quality and adherence to ICH/GCP standards.

Skills & Requirements

Must-have

  • 7 years progressive clinical research experience
  • ICH/GCP and local regulatory compliance knowledge
  • Site feasibility and start-up execution skills
  • Central IRB set-up and close-out leadership
  • SSU metrics monitoring and KPI management

Nice-to-have

  • Hematology or Oncology therapeutic area expertise
  • Spanish language proficiency
  • Process improvement and best practice drive
  • Collaborative spirit and team mentoring
  • Strategic site selection recommendations

Key Requirements

  • Bachelor's degree in scientific or healthcare discipline
  • Minimum 7 years of progressive clinical operations experience
  • Line management and supervisory experience required
  • Fluent English communication skills mandatory

Work Rights

Not specified

Tailored Resume

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