Manager/Senior Manager, Regional Clinical Compliance

About this role

About us
BeOne 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 BeOne, please visitwww.beonemedicines.comand follow us on LinkedIn and X (formerly known as Twitter).
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Job Description:

General Description:

• The Regional Clinical Compliance Manager is responsible for implementing Global Clinical Compliance and Inspection Management strategy across BeOne 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 BeOne 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 BeOne 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 BeOne 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 BeOne 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 Senior Manager with Study Supporting Role:

• Provide GCP compliance guidance and support to BeOne 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.

• 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

• 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 BeOne SOP.

• Support preparation, hosting and management of 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 and remote Compliance assessment scheduling and preparation for assigned studies.

• Peer review compliance reports for visit targeting their assigned studies.

• Plans and conducts Remote Site Compliance Review (RSCR) at identified investigator site(s) and country level 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

• 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

• Conducts or supports trend analysis to identify potential compliance risks associated with study delivery.

• Supports RCC management in tracking Key Compliance Indicators (KCI) and…