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.
Ensures SSU clinical trial activities are executed to expected and specified timelines and quality standards.
Proactively seeks opportunities to lead and drive improvements to optimize efficiencies within the SSU Team as well as the within the greater Americas region (U.S., Canada, Latin America).
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
SSU onboarding and process improvement
Site feasibility and start-up
Document management and negotiation
Nice-to-have
Scientific and business professionals
Highly motivated and collaborative
Passionate interest in fighting cancer
Spanish language skills
Mentoring and training team members
Key Requirements
Minimum 7 years progressive experience
Bachelor's degree or higher in scientific/healthcare