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 Compliancer supports inspection readiness, preparation, hosting, response management and further lesson-learned development, as assigned. 

Essential Functions of Manager GCP Compliance with Site Supporting Role: 

• Support the management and oversight of site quality and compliance for their assigned studies, to ensure: 

• The protection of the rights, safety, and well-being of study subjects 

• The integrity and validity of clinical study data  

• Adherence to the protocol, ICH GCP, the applicable regulatory requirement(s) and SOPs 

• Support Remote Compliance Review targeting business-critical clinical studies to detect potential non-compliance risk, issues and assess the inspection steady status of identified studies.  

• Performs periodic risk evaluations for assigned studies to identify investigator sites showing signals of non-compliance by reviewing and comparing existing study data and collaborating with relevant stakeholders, e.g. regional & country GCO, Study RCC counterparts,  g/rCSMs, CRAs and relevant line managers. 

• Plans and conducts Remote Site Compliance Review (RSCR) at identified investigator site(s) to observe and assess the quality of the monitoring and study conduct at site(s), and proactively identify compliance issues at site, study, and/or monitoring level.  

• Plans and conducts On-Site Compliance Visits (SCVs) at identified investigator site(s) to observe and assess the quality of the monitoring and study conduct at site(s), and proactively identify compliance issues at site, study, and/or monitoring level. 

• Evaluates the quality and integrity of site practices, escalating quality and/or GCP non-compliance issues to investigators, site staff and internal GCO team as appropriate 

• Assesses classification and severity of on-site and remote compliance assessments issues identified per appropriate SOPs and shares SCV outcome with relevant BeiGene stakeholders.  

• Completes on-site and remote compliance assessments reports within BeiGene-specified timelines per SOP. 

• Follows up with action owners and key stakeholders, such as the CRA(s), CRA Line Manager, Country / Functional representative, and Clinical Study Managers to support the timely resolution of reported on-site and remote compliance assessments observation and ensure appropriate corrective and preventive action plan (CAPA) is implemented to address observations and mitigate related risks. Ensure that action owners are clearly identified for each on-site and remote compliance assessments observation and CAPA developed within timelines as specified in relevant BeiGene SOPs. 

• Ensure that all relevant Global Clinical Compliance (GCC) & Regional Clinical Compliance (RCC) systems and tools used to schedule and document on-site and remote compliance assessments management activities, identify site at risk for on-site and remote compliance assessments, report on-site and remote compliance assessments outcomes and follow-up on CAPAs resolution are maintained up to date. 

• Supports trend analysis using on-site and remote compliance assessments observations and supports compliance dashboard development and maintenance, support ongoing risk assessment to ensure quality standards are being met and address concerns associated with study delivery at sites. Supports RCC management in tracking Key Compliance Indicators (KCI) and generate metrics accordingly. 

• Support preparation, hosting and management of site inspections. 

• Supports development and implementation of satisfactory CAPA, addressing site audit / site inspection findings within agreed timelines. 

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

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 50-75% travel