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.
Lead for central IRB set-up through close-out and key contact for SSU onboarding and process improvement in the Americas.
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
ICH/GCP and local regulations
Study start-up delivery
Central IRB set-up
Process improvement
SSU metrics and KPIs
Clinical trial submissions
Nice-to-have
Scientific and business professionals
Collaborative and motivated
Fighting cancer passion
Spanish language proficiency
Key Requirements
7 years progressive experience in clinical research
Bachelor's degree or higher in scientific/healthcare