Regional Clinical Compliance Manager
Pubblicato il 31-07-2026 - Altro in Lazio
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 Associates, 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; MS Office skills (Outlook, Word, Excel, PowerPoint).
Other Qualifications
Not applicable.
Travel
Up to *****% travel.
Salary Range (Italy)
59,****** EUR - 74,****** 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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