Regional Clinical Compliance Optimization Lead

General Description:

TheRegional Clinical Compliance(RCC)OptimizationLeadis responsible forproactivelyidentifyingsignals, trends, and systemic issues acrosscountries andEMEAregionto drive continuous improvement in clinical trialexecution andprocesses. This role plays a key part in translating operational insights into actionable improvements, partnering with Global Clinical Compliance, RBQM (Risk-Based Quality Management), and global process owners to enhance efficiency, compliance, and quality across the organization.Collaborates closely with RCC InspectionLeadand RCCLead(includingCountry RCCsas needed).

Essential Functionsof the Job:

Signal Detection & Trend Analysis

• Identifyandanalyzesignals, trends, and systemic issues across EMEA using compliance-generateddata, audit findings, inspection outcomes, and operational insights.

• Translate aggregated insights into meaningful risk patterns and improvement opportunities.

• Provide regular reporting and recommendations to stakeholders to support informed decision-making.

Process Improvement & Risk Management

• Propose and support process improvements based onidentifiedtrends and systemic issues.

• Collaborate closely with RBQM teams to integrate findings into process risk assessment and risk mitigation strategies.

• Ensure alignment of improvements with GCP requirements, company procedures, and quality standards

• Identifyareas ofadditionaltrainingand supportforpreparing and delivering such educationalsessionswithintheEMEA region

Operational Excellence & Implementation

• Support regional and country-level process improvement initiatives to enhance efficiency, compliance, and consistency.

• Act as a liaison between regional/country teams and Global Clinical Compliance and global process owners.

• Facilitate theregionalimplementation of improvementsidentifiedatglobal,localor regional levels, ensuring scalability and sustainability.

• Promote best practice sharing across countries and regions.

Stakeholder Collaboration & Influence

• Partner cross-functionallywith Clinical Operations, Quality Assurance, RBQM, and Global Compliance teams.

• Influence stakeholders at multiple levels to drivethe adoptionof process enhancements.

• Support change management activities related to new or updated processes.

Supervisory Responsibilities:Notapplicable

Computer Skills:PC literacyrequired;MS Officeskills (Outlook, Word, Excel, PowerPoint)

Requirements

• Experience with RBQM principles, risk identification, and data-driven decision-making.

• Experience in process improvement, operational excellence, or quality initiatives.

• Certification in quality management, clinical research, or process improvement methodologies (e.g., Lean Six Sigma) will be a plus

• Experience supporting or implementing global process changes

• Experiencein oncologyglobal trials is preferred.

Travel:upto10%travel