Manager, Regional Clinical Compliance, APAC

Manager, Regional Clinical Compliance, APAC

Manager, Regional Clinical Compliance, APAC

Apply locations Malaysia - Home Office time type Full time posted on Posted 2 Days Ago job requisition id R28058

About us

BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).

Job Description:

General Description:

• The Regional Clinical Compliance Manager 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 Regional Clinical Compliance Manager, 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 Regional Clinical Compliance Manager 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 Regional Clinical Compliance Manager 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 Regional Clinical Compliance Manager 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 Regional Clinical Compliance Manager 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 Regional Clinical Compliance Manager 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 Regional Clinical Compliance Manager demonstrates BeiGene clinical operations knowledge, organizational skills, project management and leadership competencies.
• The Regional Clinical Compliance Manager supports inspection readiness, preparation, hosting, response management and further lesson-learned development, as assigned.

Essential Functions of Regional Clinical Compliance Manager with Study and Site 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.
• 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.

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 a multi-cultural setting and effectively handle multiple priorities in a fast-paced environment.

Qualification Required:

Education Required:

• Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline with a minimum of 5-7 years of progressive experience in clinical operations roles.
• Minimum 5-7 years’ experience in a GCP compliance or equivalent role (i.e. quality) is preferred.
• Experience in oncology global trials is preferred.

Travel: up to 50% travel.

What We Offer To Our Valued Employees:

• Market competitive compensation package including performance-based annual bonus scheme.
• Company shares (generous welcome grant and performance-based annual equity plan!).
• In-house and external learning and development opportunities.
• Fantastic benefits program and keep improving!
• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
• Join us and Make momentum in your career!

BeiGene is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.