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

Regional Clinical Compliance Manager

Animatore Turistico - HOTEL / VILLAGGI

Recruiter per affiliazione point luce e gas

Ricevi nuove offerte di lavoro

Badante part time - desio (mb)

Promoter Telefonia - UNIEURO - C.C. LE VELE