Associate Director EU CTR Strategy & Operations Excellence Lead

Job Scope

The Associate Director, EU CTR Strategy & Operations Excellence supports the Head of EU CTR in providing leadership and strategic oversight for the implementation, optimization, and continuous improvement of all EU Clinical Trials Regulation (EU CTR) processes within the organization. This role ensures consistent process execution, compliance, and operational excellence across CTIS (Clinical Trials Information System) submissions and lifecycle management activities. Acting as the process owner and operations excellence lead, the role focuses on developing and maintaining frameworks, training programs, and controls that enable a harmonized and compliant EU CTR fit for purpose operating model across all member states.

Strategic Process Governance and Oversight

• Define and maintain the EU CTR operating model, standard procedures, RACI frameworks, and control mechanisms.
• Establish oversight routines, KPIs, and performance dashboards to ...