Senior Global Clinical Study Manager/Associate Director

Senior Global Clinical Study Manager/Associate Director 发布于 2026-07-24 MJ022673 MJ022673 | GCO, Program & Study Management GCO, Program & Study Management | 全职 全职 | 上海市 北京市 上海市 北京市 General Description: Accountable for global study delivery with appropriate inspection readiness quality, within agreed timelines and budgetLeads all aspects of assigned clinical study(ies)Leads global cross-functional study team (including oversight of external partners) and acts as point of escalation for resolution of issues within assigned study(ies)Ensures alignment of study goals with clinical operations and corporate goals and objectivesContributes to development of global tools and standards, leads the development of work instructions and SOPs as requiredEssential Functions of the job: Cross-Functional LeadershipLeads the global cross-functional study team effectively, ensures effective decision making and acts as point of escalation for resolution of study related issuesLeads external vendors involved in study deliveryBuilds trust and relationship with regional subject matter experts and supports the delivery of their local study objectivesCollaborates with key stakeholders across the organization and provides regular updates on study progress to senior management as requiredRepresents the study team at internal meetings and leads the cross-functional Clinical Study Team (CST) meetings Planning and ExecutionLeads planning and management of the assigned clinical study(ies) from feasibility through closeout activitiesGenerates, manages, maintains, and communicates high quality study timelines and tracks progress towards theseEnsures that the clinical studies are operationally feasible, oversees trial feasibility, trial allocation and site selection process across all regionsEnsures timely availability of high-quality study documents to allow study submission to regulatory authorities and ECs/IRBsProvides oversight to study start up and site activation plansEnsures study plans (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, ...) are created, updated and distributed timely and implemented appropriatelyEnsures study systems and tools are set up timely, correctly and are functioning properly. Ensures study level information is updated on an ongoing basis in all systemsEnsures relevant study specific training is developed and implemented and ensures training records are well documented and filedEnsures Trial Master File for study is created, maintained and QC’d on a regular basis as per the study TMF QC planCollaborates closely with Global Clinical Supplies to forecast study drug and timely delivery of supplies to sitesSupports and as needed drives overall data cleaning timelines in close collaboration with Data Management and other stakeholders (including but not limited to regional clinical operations teams and medicator monitor)Ensures planning and execution of the Clinical Study Report in collaboration with Medical Writing and relevant CST membersQuality and Risk ManagementMonitors study activities to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulationsEnsures inspection readiness at any point in time throughout the study life cycleWorks with cross-functional study team to identify, interpret, and evaluate issues on the study and ensures corrective and preventative actions are implementedEnsures senior management and other key stakeholders are informed of risks and challenges and ensures risk mitigation plans are put in place and implementedPrepares team for quality assurance audits and inspectionsCollaborates with CST members and other colleagues to ensure cross-team, site learnings, and best practices are sharedLeads improvements and partners with study team members to enhance the efficiency and the quality of the work performed on assigned studiesLeads development, optimization and review of work instructions and SOPs as requiredBudget and ResourcesWorks with the sourcing team to select and manage study vendors, approving invoice payment throughout the studyManages study budgets, including baseline budget evaluation, change control, study closure budget, budget endorsement by senior managementAdheres to clinical study budgeting processes and provides input to finance on budget accruals and forecastsIdentifies and manages study team resource needs and establishes contingency plans for key resources.Monitors resource utilization over the study life cycleEnsures clinical studies at a project level are executed within endorsed time, quality, and cost parametersSupervisory Responsibilities:  Provides performance feedback on team members as requiredMentors more junior team membersEducation Required: Bachelor’s Degree in a scientific or healthcare discipline required* minimum of 7+ years of relevant clinical research experience. Higher Degree preferred*exceptions might be made for candidates with relevant clinical operations experienceComputer Skills:   MS Office, Project Planning Applications, Clinical Trial Management SystemsOther QualificationsProven project management experienceOncology experience preferredIn depth knowledge of clinical operations methodologies, in depth understanding of all aspects of clinical study processesAble to independently lead large and/or complex global clinical studies7 or more years of progressive experience in clinical research within biotech, pharma or CRO industryTravel: Limited travel required百济神州全球胜任力 当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 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 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. Due to the reasonable business need for human resource management as a result of BeOne’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeOne Job Applicant Privacy Policy (BeOne official website - Privacy Policy - Job Applicant Privacy Policy). If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any oth

er personal information. General Description: Accountable for global study delivery with appropriate inspection readiness quality, within agreed timelines and budget Leads all aspects of assigned clinical study(ies) Leads global cross-functional study team (including oversight of external partners) and acts as point of escalation for resolution of issues within assigned study(ies) Ensures alignment of study goals with clinical operations and corporate goals and objectives Contributes to development of global tools and standards, leads the development of work instructions and SOPs as required Essential Functions of the job: Cross-Functional Leadership Leads the global cross-functional study team effectively, ensures effective decision making and acts as point of escalation for resolution of study related issues Leads external vendors involved in study delivery Builds trust and relationship with regional subject matter experts and supports the delivery of their local study objectives Collaborates with key stakeholders across the organization and provides regular updates on study progress to senior management as required Represents the study team at internal meetings and leads the cross-functional Clinical Study Team (CST) meetings Planning and Execution Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities Generates, manages, maintains, and communicates high quality study timelines and tracks progress towards these Ensures that the clinical studies are operationally feasible, oversees trial feasibility, trial allocation and site selection process across all regions Ensures timely availability of high-quality study documents to allow study submission to regulatory authorities and ECs/IRBs Provides oversight to study start up and site activation plans Ensures study plans (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, ...) are created, updated and distributed timely and implemented appropriately Ensures study systems and tools are set up timely, correctly and are functioning properly. Ensures study level information is updated on an ongoing basis in all systems Ensures relevant study specific training is developed and implemented and ensures training records are well documented and filed Ensures Trial Master File for study is created, maintained and QC’d on a regular basis as per the study TMF QC plan Collaborates closely with Global Clinical Supplies to forecast study drug and timely delivery of supplies to sites Supports and as needed drives overall data cleaning timelines in close collaboration with Data Management and other stakeholders (including but not limited to regional clinical operations teams and medicator monitor) Ensures planning and execution of the Clinical Study Report in collaboration with Medical Writing and relevant CST members Quality and Risk Management Monitors study activities to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations Ensures inspection readiness at any point in time throughout the study life cycle Works with cross-functional study team to identify, interpret, and evaluate issues on the study and ensures corrective and preventative actions are implemented Ensures senior management and other key stakeholders are informed of risks and challenges and ensures risk mitigation plans are put in place and implemented Prepares team for quality assurance audits and inspections Collaborates with CST members and other colleagues to ensure cross-team, site learnings, and best practices are shared Leads improvements and partners with study team members to enhance the efficiency and the quality of the work performed on assigned studies Leads development, optimization and review of work instructions and SOPs as required Budget and Resources Works with the sourcing team to select and manage study vendors, approving invoice payment throughout the study Manages study budgets, including baseline budget evaluation, change control, study closure budget, budget endorsement by senior management Adheres to clinical study budgeting processes and provides input to finance on budget accruals and forecasts Identifies and manages study team resource needs and establishes contingency plans for key resources. Monitors resource utilization over the study life cycle Ensures clinical studies at a project level are executed within endorsed time, quality, and cost parameters Supervisory Responsibilities: Provides performance feedback on team members as required Mentors more junior team members Education Required: Bachelor’s Degree in a scientific or healthcare discipline required* minimum of 7+ years of relevant clinical research experience. Higher Degree preferred *exceptions might be made for candidates with relevant clinical operations experience Computer Skills: MS Office, Project Planning Applications, Clinical Trial Management Systems Other Qualifications Proven project management experience Oncology experience preferred In depth knowledge of clinical operations methodologies, in depth understanding of all aspects of clinical study processes Able to independently lead large and/or complex global clinical studies 7 or more years of progressive experience in clinical research within biotech, pharma or CRO industry Travel: Limited travel required 百济神州全球胜任力 当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 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 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. Due to the reasonable business need for human resource management as a result of BeOne’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeOne Job Applicant Privacy Policy (BeOne official website - Privacy Policy - Job Applicant Privacy Policy). If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information. 立即投递