Regional Clinical Compliance Manager

BeOne Medicines; Italia; In loco; EUR 59.000 - 74.000; Tempo pieno

Descrizione del lavoro

BeOne Medicines is seeking a Regional Clinical Compliance Country Manager to oversee country and site level trial compliance, applying a risk-based approach to ensure GCP adherence, patient safety, data integrity, and inspection readiness.

You will partner with global stakeholders, lead risk assessments, site visits for high-risk sites, manage CAPAs, and support audits and inspections, requiring a BS/BA in a scientific field and at least 5 years in clinical operations with 4 years in a

Competenze

• Bachelor’s degree in a scientific or healthcare discipline with a minimum of 5 years in clinical operations, plus 4 years in a GCP compliance or quality role preferred.
• Oncology global trials experience preferred; exceptions may be made for equivalent relevant experience.

Mansioni

• Serve as the primary contact for country teams on GCP requirements and procedures.
• Provide guidance on regulations to ensure compliant practices.
• Analyze country/site risks and lead risk-based oversight and site visits for high-risk sites.
• Support CAPAs and assist with audit and inspection readiness.

Conoscenze

GCP knowledge

Analytical skills

Attention to detail

Stakeholder management

English & Italian

Organizational skills

Independent work

Formazione

BS/BA in science or healthcare

Strumenti

MS Office

Descrizione del lavoro

• General compliance-related queries

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:

20% or less

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

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.