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Manager, Regional Clinical Compliance, JAPAC

Manager, Regional Clinical Compliance, JAPAC

BeiGeneMalaysia, Home
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Manager, Regional Clinical Compliance, JAPAC

Manager, Regional Clinical Compliance, JAPAC

BeiGeneMalaysia, Home
30+ hari lalu
Penerangan pekerjaan

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
  • 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

    • Qualification Required :

    Education 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.
  • Minimum 5-7 years’ experience in a GCP compliance or equivalent role (i.e. quality) is preferred.
  • Experience in oncology global trials is preferred.
  • exceptions may be made for candidates with equivalent appropriate Clinical Operations experience.

    • Supervisory Responsibilities :

  • Not applicable

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

    Other Qualifications : Not applicable

    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!

    • 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.

    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