Regional Clinical Compliance Manager

31 ago - Roma
Beigene

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.

Possiede le competenze, l'esperienza e la determinazione necessarie per avere successo in questo ruolo? Lo scopra qui sotto.

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 ExpertServe as the primary point of contact for country teams regarding:GCP requirementsCompany and study-specific proceduresGeneral compliance-related queriesProvide expert guidance and interpretation of regulations and internal standards to ensure consistent and compliant practices.Risk-Based Country and Site OversightAnalyze 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 complianceAlign 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:Histori

Addetto al centralino

31 ago - Castel Volturno
gyf srls

Docente/ Formatore

31 ago - Olbia
olbia formazione

Ricevi nuove offerte di lavoro

Crea una Job Alert gratuita per regional clinical compliance manager / roma

Agente di Commercio Monomandatario - Settore Alime

31 ago - Vicenza
la patata di fabris giulia

Impiegata

31 ago - Chiari
ALICE COSTRUZIONI