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
SSU metrics and KPIs
Process improvement leadership
Central IRB management
Site feasibility and activation
Nice-to-have
Scientific and business professionals
Collaborative and passionate interest
Fighting cancer
Spanish language proficiency
Risk mitigation skills
Mentoring and training team members
Key Requirements
Minimum 7 years progressive experience
Bachelor's degree or higher in scientific/healthcare discipline preferred
Clinical research and operations experience
Biotech, pharmaceutical, or CRO environment experience