Clinical Research Operations Lead

Regulatory Jobs; United States; Remote; USD 106,000 - 141,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) plan

FSA/HSA

Life Insurance

Paid Time Off

Wellness program

Job summary

BeOne Medicines Ltd. seeks an Associate CRM to oversee clinical monitoring activities and manage the CRA team, ensuring compliance with ICH-GCP, SOPs, and local regulations. As a line manager, you will guide performance, provide development opportunities, and foster a positive team culture.

The role requires at least 5 years in pharma/CRO, oncology experience preferred, and fluency in English. Travel is required; strong communication and organizational skills are essential.

Qualifications

• Minimum 5 years of industry experience in the pharmaceutical or CRO or relevant field.
• Thorough understanding of the drug development process, including expert knowledge of international standards (ICH-GCP) and health authority requirements.
• Experience in monitoring and trial execution, with prior CRA experience preferred.
• Excellent interpersonal, organizational, and written/verbal communication skills.
• Oncology experience is highly recommended.
• Fluent in written and verbal English.

Responsibilities

• Allocate CRA resources and perform ongoing resource assessments to ensure a balanced workload and meet study deliverables.
• Ensure CRAs have the required level of monitoring knowledge and skills to perform activities with high quality.
• Lead and manage CRA performance and quality indicators per ICH-GCP, SOPs, and local regulations.
• Strengthen site relationships to enhance performance and uphold the company’s trial delivery reputation.
• Review monitoring quality and resolve issues to ensure regulatory compliance with ICH-GCP and guidelines.
• Support site audits/inspections and ensure corrective actions.
• Recruitment and onboarding of team members; assign tasks and manage performance.
• Mentor and develop team members; promote growth and collaboration across functions.
• Travel as required; maintain valid driver’s license.

Skills

Leadership

Team management

Project management

Communication

Analytical thinking

Education

Bachelor’s degree or higher in scientific or healthcare discipline

Advanced degrees preferred

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

BeOne Medicines Ltd. seeks an Associate CRM to oversee clinical monitoring activities and manage the CRA team, ensuring compliance with ICH-GCP, SOPs, and local regulations. As a line manager, you will guide performance, provide development opportunities, and foster a positive team culture.

The role requires at least 5 years in pharma/CRO, oncology experience preferred, and fluency in English. Travel is required; strong communication and organizational skills are essential.