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.

Communicate 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

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

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

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📌 Regional Clinical Compliance Manager (Roma)
🏢 Altro
📍 Roma