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.
Gathers and monitors start-up metrics to measure against KPIs and actively drives best practices and process improvement to effectively achieve SSU goals.
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
Study start-up delivery
ICH/GCP and local regulations
Central IRB set-up
Site feasibility and activation
Submission dossiers to Ethics Committees
Document management and negotiation
Nice-to-have
Scientific and business professionals
Highly motivated and collaborative
Passionate interest in fighting cancer
Process improvement and optimization
Mentoring and training team members
Key Requirements
Minimum 7 years progressive experience
Bachelor's degree or higher in scientific/healthcare