Manager/Senior Manager, Regional Clinical Compliance, JAPAC position at BeOne Medicines.| South Korea

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BeOne Medicines Manager/Senior Manager, Regional Clinical Compliance, JAPAC

Experience: 7-years

Pattern: full-time

Country:

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Associate

Seoul....South Korea

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 visit www.beonemedicines.com and 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 /Senior Manager is responsible for implementing Global Clinical Compliance and Inspection Management strategy across B eO ne Clinical activities at global, regional, country, site and/or study levels. The Regional Clinical Compliance Manager /Senior Manager , independent from the Clinical Study Team (CST), provides compliance oversight as well as quality support to B eO ne 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 /Senior 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 /Senior 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 /Senior 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 Be O ne 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 /Senior Manager adheres to ICH/GCP, local regulations, applicable Be O ne SOPs and contributes to the development and/or review of Clinical Operations Work Instructions and SOPs. The Regional Clinical Compliance Manager /Senior 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 /Senior Manager demonstrates Be O ne clinical operations knowledge, organizational skills, project management and leadership competencies. The Regional Clinical Compliance Manager /Senior Manager supports inspection readiness, preparation, hosting, response management and further lesson-learned development, as assigned. Qualification Required: Education /Experience Required: Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline* with minimum of 5-7 years of progressive experience in clinical operations roles. 10+ years’ experience for Senior Manager Minimum 5-7 years’ experience in a GCP compliance or equivalent role (i.e. quality) is preferred. 10+ years’ experience for Senior Manager Experience in oncology global trials is preferred. *exceptions may be made for candidates with equivalent appropriate Clinical Operations experience. Essential Functions of Regional Clinical Compliance Manager /Senior Manager with Study and Site Supporting Role: Responsible to 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. 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 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 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 BeOne stakeholders. Completes on-site and remote compliance assessments reports within BeOne-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 BeOne 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 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! BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity BeOne 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. Due to BeOne’s global operation, job applicants’ data will be stored in Workday (currently located in the U.S.). Besides, job applicants’ data will be kept for one year to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy ( https://beonemedicines.com/privacy-policy ). If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you have any concern, please DO NOT provide any resume or other personal information to us.

Manager/Senior Manager, Regional Clinical Compliance, JAPAC job opportunity at BeOne Medicines.

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