Regional Clinical Compliance Lead

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

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