Manager, Regional Clinical Compliance GCP

About the role

The Manager, Regional Clinical Compliance is responsible for implementing Global Clinical Compliance (GCC) and Inspection Management strategy across BeOne Clinical activities at regional, country, study and/or site levels. This position provides compliance oversight and quality support to BeOne GCO study teams, ensuring appropriate GCO study conduct, inspection readiness, and overall compliance to applicable regulatory requirements.

Responsibilities

• Supports timely identification of non-compliance issues and quality events, ensuring appropriate escalation and potential misconduct reporting.
• Tracks and trends non-compliance issues, quality events, and other relevant observations during Site Compliance Visits (SCV).
• Develops and implements best practices, leads improvements, and optimizes effectiveness and efficiency within the Global and Regional Clinical Compliance team, as well as within the Global and Regional Clinical Operations team.
• Supports Global and Regional Clinical Compliance in the development of subsequent GCP readiness activities and programs.
• Conducts peer reviews of site compliance visit reports.
• Supports inspection readiness, preparation, hosting, response management, and further lesson-learned development as assigned.

Requirements

• Significant clinical study experience and understanding of investigational site setup, trial management, and conduct at a study and site level.
• Organizational, project management, and leadership skills.
• Excellent English written and verbal communication and interpersonal skills.
• Excellent organizational skills and ability to prioritize and multi-task.
• Ability to work independently in a multi-cultural setting and handle multiple priorities in a fast-paced environment.

Qualifications

• Bachelor’s degree (BS/BA or equivalent) in a scientific, medical, or healthcare discipline.
• Minimum of 5 years of progressive experience in clinical operations roles.
• Minimum 2 years’ experience in a GCP compliance or equivalent role (i.e. quality).
• Experience in oncology global trials is preferred.

Skills

• Understanding of clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatory guidelines.
• Analytical and problem-solving skills.
• Organizational, project management, and leadership skills.
• Excellent English written and verbal communication and interpersonal skills.
• Excellent organizational skills and ability to prioritize and multi-task.
• Ability to work independently in a multi-cultural setting and effectively handle multiple priorities in a fast-paced environment.

Benefits

BeOne offers a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. The Company also has a stock ownership program and an annual bonus plan for eligible employees.

Pay

$118,600.00 - $158,600.00 annually

Schedule

Up to 50-75% travel is expected.