Clinical Site Operations Leader

CSL Ltd. ADR; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

CSL Behring seeks an experienced clinical operations leader to oversee site management and monitoring across the Americas. You will coordinate CSAs, ensure regulatory compliance (ICH/GCP), and drive quality in multicenter studies while aligning regional activities with global strategies.

The role requires extensive CRO management experience, strong cross-functional collaboration, and a focus on audit readiness and risk mitigation. Up to 50% travel within the Americas region may be required.

Qualifications

• Bachelor’s degree in the life sciences or related field.
• 8+ years clinical operations experience in pharma.
• 4+ years clinical site monitoring including 2+ years managing CRAs.
• Solid understanding of drug development and clinical trial process.
• Experience managing CROs.
• Audit readiness and inspection experience.
• ICH guidelines/GCP knowledge.
• Experience training CRO staff and junior staff.

Responsibilities

• Oversee quality and compliance of clinical program execution.
• Lead site recruitment and feasibility input.
• Develop oversight plans (SMMOP, CMP) and ensure regulatory compliance.
• Manage CRO recruitment, RFP reviews, and vendor relationships.
• Engage sites and drive continuous improvement in site performance.
• Coordinate with clinical development, regulatory, and medical affairs to align regional and global strategies.

Skills

Leadership

Communication

Regulatory knowledge

Problem solving

Site monitoring

Vendor management

Education

Bachelor’s degree in life sciences

Job description

CSL Behring seeks an experienced clinical operations leader to oversee site management and monitoring across the Americas. You will coordinate CSAs, ensure regulatory compliance (ICH/GCP), and drive quality in multicenter studies while aligning regional activities with global strategies.

The role requires extensive CRO management experience, strong cross-functional collaboration, and a focus on audit readiness and risk mitigation. Up to 50% travel within the Americas region may be required.