The role is accountable for delivering study start-up activities and ongoing submissions within established timelines while adhering to ICH/GCP and local regulations
Job Summary
The role is accountable for delivering study start-up activities and ongoing submissions within established timelines while adhering to ICH/GCP and local regulations.
Candidates must demonstrate mastery of SSU skills, manage resources, and provide strategic recommendations on site selection to achieve First Patient In (FPI) goals.
BeOne seeks professionals who share a passionate interest in fighting cancer and are highly motivated to drive process improvements across the Americas region.
Matching Summary
The role is accountable for delivering study start-up activities and ongoing submissions within established timelines while adhering to ICH/GCP and local regulations.
Skills & Requirements
Must-have
7 years clinical research experience
ICH/GCP and local regulation knowledge
SSU lead and site activation expertise
Fluent English language proficiency
Americas region operational oversight
Nice-to-have
Spanish language skills
Hematology or Oncology therapeutic area
Process improvement and best practices
Collaborative and motivated mindset
Passionate interest in fighting cancer
Key Requirements
Bachelor's degree in scientific or healthcare discipline
Minimum 7 years progressive experience in clinical operations
Experience in biotech, pharmaceutical sector, or CRO environment
Line management and mentoring experience required
Functional Service Provider model knowledge preferred