Regional Clinical Compliance Manager

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

Regional Clinical Compliance Country Manager is responsible for ensuring robust oversight of clinical trial compliance at the country and site level. This role applies a risk-based approach to proactively identify, evaluate, and manage compliance risks, ensuring adherence to Good Clinical Practice (GCP), company procedures, and regulatory requirements. The role partners closely with country, regional and global stakeholders to safeguard patient safety, data integrity, and inspection readiness.

Essential Functions of the Job:

Compliance Subject Matter Expert

Serve as the primary point of contact for country teams regarding:

GCP requirements

Company and study-specific procedures

General compliance-related queries

Provide expert guidance and interpretation of regulations and internal standards to ensure consistent and compliant practices.

Risk-Based Country and Site Oversight

Analyze and confirm initial country and site-specific risks, including identification of critical data and key processes.

Communicates identified country and site trends, lessons learned with Clinical Operations functions for continuous improvement of study conduct compliance

Align with Global Clinical Compliance on the execution of the Study Health Check Plan at country and site level.

Lead and support key process reviews through remote desk checks, ensuring alignment with Clinical Research Associated, Clinical Study Managers (CSMs) and respective Line Managers.

Identify high-risk sites using a structured, risk-based approach, including but not limited to:

Historical performance and inspection outcomes

Planned and actual recruitment volumes

Feasibility assessments and risks identified during site selection and qualification

Non-compliances identified during the study conduct

Conduct Site Compliance Visits on identified high risk sites on a risk-based approach

Issue Management & Audit and Inspection Support

Support country teams in identifying, managing, and resolving compliance issues.

Support and manage individual Corrective and Preventive Actions (CAPAs) to ensure issues/deviations are thoroughly evaluated (including a risk assessment, root cause analysis and effectiveness measures) and identified actions are addressed in a timely manner.

As needed, support the Regional Clinical Compliance Inspection and Audit Support team, providing input to enable the preparation and conduct of the site audits and inspections

Core Competencies, Knowledge and Skill Requirements:

Understanding of clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatory guidelines

Analytical and problem-solving skills

High attention to detail and quality orientation

Excellent communication and stakeholder management skills

Communication & Interpersonal Skills:

Excellent English and Italian written and verbal communication and interpersonal skills

Excellent organizational skills and ability to prioritize and multitask

Ability to work independently in a multi-cultural setting and effectively handle multiple priorities in a fast-paced environment

Education Required:

Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline* with a minimum of 5 years of progressive experience in clinical operations roles plus minimum 4 years’ experience in a GCP compliance or equivalent role (i.e. quality) is preferred.

Experience in oncology global trials is preferred.

exceptions may be made for candidates with equivalent appropriate Clinical Operations experience.

Supervisory Responsibilities:

Not applicable

Computer Skills: PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Other Qualifications: Not applicable

Travel: up to 20-30% travel

Salary Range Italy: 59,200.00 EUR - 74,000.00 EUR

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters Teamwork

Provides and Solicits Honest and Actionable Feedback

Self-Awareness

Acts Inclusively

Demonstrates Initiative

Entrepreneurial Mindset

Continuous Learning

Embraces Change

Results-Oriented

Analytical Thinking/Data Analysis

Financial Excellence

Communicates with Clarity