Senior Clinical Study Start-Up Strategist

BeiGene; United States; Remote; USD 54,000 - 67,000; Full time

Job summary

BeOne seeks a Clinical Start-Up Specialist to manage site start-up and submission tasks across North America. The role emphasizes ICH/GCP adherence, regulatory compliance, and document management to ensure timely activations.

Responsibilities include coordinating IRB submissions, maintaining CTMS SSU data, and improving start-up processes. A bachelor’s degree and 3+ years in clinical research are required for this position.

Qualifications

• Bachelor’s degree in science or healthcare required or equivalent
• Minimum 3 years in clinical research/clinical operations in biotech/pharma/CRO/site environment
• Familiar with ICH/GCP and local regulations
• Strong document management and negotiation skills

Responsibilities

• Lead site start-up activities and activation timelines
• Manage ICF/submissions and IRB coordination
• Maintain SSU data entry in CTMS and timely eTMF filing
• Support development of local workflows to improve output
• Contribute to SSU infrastructure improvements in North America
• Perform additional tasks to meet project goals

Skills

ICH/GCP knowledge

Regulatory compliance

SOP adherence

CTMS data entry

eTMF filing

Site start-up

Documentation management

Education

Bachelor’s degree in scientific/healthcare discipline

Tools

CTMS

eTMF systems

Job description

BeOne seeks a Clinical Start-Up Specialist to manage site start-up and submission tasks across North America. The role emphasizes ICH/GCP adherence, regulatory compliance, and document management to ensure timely activations.

Responsibilities include coordinating IRB submissions, maintaining CTMS SSU data, and improving start-up processes. A bachelor’s degree and 3+ years in clinical research are required for this position.