BeiGene
Regional Clinical Compliance Manager
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BeOne: Regional Clinical Compliance Country 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.
- Serve as the primary point of contact for country teams regarding:
-
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.
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- 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)
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Other Qualifications:
- Not applicable
Travel:
- up to 20-30%
Salary Range EU:
- 63,200.00 GBP - 79,000.00 GBP
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.
About BeOne:
BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook, and Instagram.
For more information, please visit the link to explore job opportunities in China Mainland.
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At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.
- Patients First
- Driving Excellence
- Bold Ingenuity
- Collaborative Spirit
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