Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne’s SOPs, and local regulations
Job Summary
Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne’s SOPs, and local regulations.
Skilled in driving kick-off and completion of tasks from selection through activation, including providing timeline input for site activations.
The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
Matching Summary
Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne’s SOPs, and local regulations.
Salary
Base: $83,800.00 - $113,800.00 annually; Bonus/Equity: eligible for annual bonus plan/discretionary equity awards/Employee Stock Purchase Plan; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness
Skills & Requirements
Must-have
ICH/GCP
local regulations/guidelines
SOPs
site selection feasibility
site activation timelines
document negotiation
central IRB submissions
essential document collection
CTMS data entry
eTMF filing
Nice-to-have
scientific and business professionals
highly motivated
collaborative
passionate interest in fighting cancer
entrepreneurial mindset
continuous learning
embraces change
results-oriented
analytical thinking/data analysis
Key Requirements
Bachelor’s degree or higher
Minimum of 3 years of progressive experience
clinical research and clinical operations experience
biotech, pharmaceutical sector, CRO, or clinical site environment