Manager GCP Compliance

General Description: 

• The Manager GCP Compliance is responsible for implementing Global Clinical Compliance and Inspection Management strategy across BeiGene Clinical activities at global, regional, country, site and/or study levels. 

• The Manager GCP Compliance, independent from the Clinical Study Team (CST), provides compliance oversight as well as quality support to BeiGene GCO study teams, for their assigned studies and ensures that appropriate GCO study conduct, inspection readiness, and overall compliance to applicable regulatory requirements is systematically maintained. 

• The Manager GCP Compliance seeks opportunities to implement best practices, share lessons learned, lead and drive improvements to optimize effectiveness and efficiency within the Global and Regional Clinical Compliance team, as well as within the Global and Regional Clinical Operations team. 

• The Manager GCP Compliance supports timely identification of non-compliance issues and quality events, ensure appropriate escalation of those issues and events as well as potential misconduct or potential Serious Breach to relevant stakeholders.   

• The Manager GCP Compliance tracks and trends  non-compliance  issues, quality events, and any other relevant  observations identified during Site Compliance Visits, to help identify issues and risks across BeiGene study programs and processes. The CCL supports Global and Regional Clinical Compliance in the development of subsequent GCP readiness activities and programs. 

• The Manager GCP Compliance adheres to ICH/GCP, local regulations, applicable BeiGene SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs.  

• The Manager GCP Compliance demonstrates significant clinical study experience and understanding of investigational site setup, trial management and conduct at a study and site level, and clinical operations processes. 

• The Manager GCP Compliance demonstrates BeiGene clinical operations knowledge, organizational skills, project management and leadership competencies. 

• The Manager GCP Compliance supports inspection readiness, preparation, hosting, response management and further lesson-learned development, as assigned. 

Essential Functions of Manager GCP Compliance with Study Supporting Role:  

• Responsible to provide GCP compliance guidance and support to BeiGene CST and other GCO stakeholders for the assigned portfolio of studies in the applicable country / region, ensuring that appropriate GCO study conduct, inspection readiness and overall compliance to applicable regulatory requirements is maintained.  

• Ensures appropriate escalation of GCP non-compliance issue and / or quality events, potential misconduct and significant deviations to relevant GCO stakeholders.  

• Supports development and implementation of satisfactory CAPA addressing GCP non-compliance issue / quality event within timelines defined in relevant BeiGene SOP.  

• Support preparation, hosting and management of site audits / site inspections.  

• Supports development and implementation of satisfactory CAPA addressing site audit / site inspection findings.  

• Supports the development of GCP inspection readiness program at study, country, regional and/or global level, as assigned.  

• Ensure GCP related audit findings are fed back into the GCP inspection readiness program or appropriate training or processes.   

• Provide input into on-site / remote Compliance Assessments scheduling and preparation for assigned studies.  

• Peer review Compliance Assessment reports for visit targeting their assigned studies.  

• Stays abreast of new and revised government, industry and company regulations, trends and interpretations by participating in trainings, conferences, workshops and discussion groups as appropriate   

• Supports trend analysis to identify potential compliance risks associated with study delivery.  

• Supports RCC management in tracking Key Compliance Indicators (KCI) and developing metrics accordingly.  

• Support development of GCP Compliance and inspection readiness training material.  

• Supports the development and implementation of internal GCP compliance process improvement strategies, tools, initiatives or workstreams.  

• Provides constructive feedback on CRAs and other team members performance to their line managers to support performance review as applicable.  

• Provide feedback on investigator site performance for future study feasibility purposes.  

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 

• Organizational, project management and leadership skills 

Communication & Interpersonal 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 multi-cultural setting and effectively handle multiple priorities in a fast-paced environment  

Computer Skills: PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint) 

Other Qualifications: Not applicable 

Travel: up to 10-15% travel