Americas Clinical Site Oversight Lead

CSL; Upper Merion Township (Montgomery County); Hybride; USD 150 000 - 210 000; Plein temps

Résumé du poste

CSL is seeking an Associate Director, Clinical Operations SMOL to lead site management and oversight for global clinical programs. You will coordinate CSAs, ensure regulatory compliance, and drive quality, timelines, and budget adherence across the Americas region.

Responsibilities include developing oversight plans, ensuring audit readiness, and managing CRO relationships, with up to 50% travel. A strong background in ICH/GCP and clinical development is required.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 8+ years clinical operations experience in pharma, global study team.
• 4+ years site monitoring experience; 2+ years managing CRAs/monitors.
• Deep understanding of drug development and clinical trials.
• Experience managing CRO relationships.
• Audit readiness and inspection experience.
• Thorough knowledge of ICH guidelines/GCP.
• Experience training CRO staff and junior staff.

Responsabilités

• Oversee sponsor oversight of site conduct and management across studies.
• Lead plans that govern quality management and conduct at sites.
• Coordinate CSAs and serve as primary contact for ESPs regionally.
• Address site-related issues and escalate as needed to study team.
• Maintain overview of site management across studies and drive corrective actions.
• Foster relationships with study sites and stakeholders.
• Provide input on feasibility and CRO budget/timelines; support on-time delivery.
• Promote CSL pipeline in the Americas; drive site performance improvements.
• Ensure adherence to international regulatory standards and timelines.

Connaissances

Strategic leadership

Clinical oversight

Vendor management

Site engagement

Cross-functional collaboration

Problem solving

ICH/GCP knowledge

Project management

Communication skills

Formation

Bachelor's degree in life sciences or related field

Description du poste

CSL is seeking an Associate Director, Clinical Operations SMOL to lead site management and oversight for global clinical programs. You will coordinate CSAs, ensure regulatory compliance, and drive quality, timelines, and budget adherence across the Americas region.

Responsibilities include developing oversight plans, ensuring audit readiness, and managing CRO relationships, with up to 50% travel. A strong background in ICH/GCP and clinical development is required.