Lead Clinical Site Ambassador

CSL - King of Prussia, PA

Full-time - Mid Level

Hybrid - King of Prussia, PA

10,001+ employees

Ambulatory Health Care Services

About the position

The Lead Clinical Site Ambassador at CSL Behring is responsible for overseeing site management activities for clinical studies, ensuring compliance with regulatory standards, and maintaining strong relationships with study sites. This hybrid role involves collaboration with various stakeholders to execute clinical trials effectively and manage the performance of Clinical Site Ambassadors (CSAs).

Responsibilities

• Responsible for overall Site Management activities of the CSAs for one or more Clinical Studies.
• Ensure activities support the TA model and are planned according to the TA strategy, regulatory standards, and within budget.
• Develop study level documents and training material aligned with the study strategy.
• Member of the Study Execution Team (SET) responsible for executing clinical trials at the site level.
• Lead CSA activities through site identification, selection, start-up, activation, maintenance, and closure.
• Manage the performance and development of CSAs that report to them, if applicable.
• Review monitoring visit reports and track actual to projected variables related to CSA and site activities.
• Collaborate with internal and external stakeholders to translate clinical development strategy into operational deliverables.

Requirements

• Bachelor's degree or equivalent in a Science-related discipline.
• 7+ years of experience in a Clinical Operations environment.
• Global Clinical Operations experience is important.
• Experience in on-site monitoring and clinical research is required.
• Knowledge of clinical trial systems and ICH GCP is important.

Benefits

• Medical, Dental, Vision
• 401K
• Paid time Off