The role is accountable for delivering study start-up activities within established timelines while ensuring compliance with ICH/GCP and local regulations
Job Summary
The role is accountable for delivering study start-up activities within established timelines while ensuring compliance with ICH/GCP and local regulations.
Candidates must demonstrate mastery of SSU maintenance activities and provide country-specific expertise to project teams across the Americas region.
BeOne seeks highly motivated professionals who share a passionate interest in fighting cancer and are committed to driving excellence in clinical operations.
Matching Summary
The role is accountable for delivering study start-up activities within established timelines while ensuring compliance with ICH/GCP and local regulations.
Skills & Requirements
Must-have
7 years progressive clinical research experience
ICH/GCP and local regulatory knowledge
Site feasibility and activation expertise
Central IRB set-up and close-out
SSU metrics and KPI monitoring
Line management and mentoring skills
Nice-to-have
Fluent Spanish language skills
Hematology or Oncology therapeutic area focus
Functional Service Provider model experience
Process improvement and best practices drive
Collaborative spirit and bold ingenuity
Key Requirements
Bachelor's degree in scientific or healthcare discipline
Minimum 7 years of progressive clinical operations experience
Experience in biotech, pharmaceutical sector, or CRO environment
Line management experience including hiring and training