Overview

Job Scope: What is this job’s focus? 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.

Key Responsibilities

• Strategic Process Governance and Oversight: Support the Head of EU CTR in defining and maintaining the EU CTR operating model, including standard procedures, RACI framewor...