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.
Demonstrates mastery of skills required to conduct SSU and maintenance activities, providing country-specific SSU expertise to project teams.
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
Study start-up delivery
ICH/GCP compliance
Local regulations adherence
Central IRB set-up
SSU process improvement
Site feasibility and activation
Nice-to-have
Scientific and business professionals
Collaborative and motivated
Passionate interest in fighting cancer
Spanish language proficiency
Key Requirements
7 years progressive experience in clinical research
Bachelor's degree or higher in scientific/healthcare discipline