Support in 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
Support in 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.
Skilled in driving kick-off and completion of tasks from selection through activation, leveraging and building upon existing site partnership data to execute start-up efficiently.
Prepare submissions dossiers to Ethics Committees and Regulatory Authorities according to applicable regulations, SOPs and work instructions.
Matching Summary
Support in 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
site feasibility and activation
submission dossier preparation
project planning and timelines
document management and negotiation
Nice-to-have
scientific and business professionals
highly motivated and collaborative
passionate interest in fighting cancer
Spanish language skills
Hematology/Oncology therapeutic area
Key Requirements
Minimum 2 years progressive experience
Bachelor's degree or higher
Scientific or healthcare discipline
Clinical research and operations experience
Biotech, pharmaceutical, CRO, or clinical site environment