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.
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).
Demonstrates mastery of skills required to conduct SSU and maintenance activities, including 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
ICH/GCP knowledge
Local regulations and SOPs
Study start-up delivery
Central IRB management
Site feasibility and activation
Submission dossier preparation
Nice-to-have
Collaborative spirit
Scientific and business professionals
Passionate interest in fighting cancer
Process improvement driver
Mentoring and training team members
Key Requirements
Minimum 7 years progressive experience in clinical research
Bachelor’s degree or higher in scientific/healthcare discipline