(Senior) Global Study Management Associate，全球项目管理助理

(Senior) Global Study Management Associate，全球项目管理助理 发布于 2026-07-24 MJ022596 MJ022596 | GCO, Program & Study Management GCO, Program & Study Management | 全职 全职 | 北京市 上海市 北京市 上海市 General DescriptionSupports the Global Clinical Study Manager in global study delivery and ensures that delegated components of clinical studies are executed to expected and specified quality standards, within timelines and budget.Supports the alignment of study goals with clinical operations goals and objectives under direction of the Global Clinical Study Manager.Demonstrates gSMA leadership capabilities and the ability to influence in a cross-functional collaboration.Strong problem-solving skills with the ability to identify issues proactively and implement effective solutions.Capable of tracking the progress of routine study tasks and ensuring the routine task requirements are met on time.Comfortable adopting and using new software and processes; demonstrates awareness and practical sense for AI applications in clinical operations.Thrives in a fast-paced, dynamic team environment with passion for collaboration and continuous improvement.​Cross-Functional Leadership Support & CollaborationSupports the Global Clinical Study Manager with the organization and logistics for cross-functional Clinical Study Team (CST) meetings (e.g., agenda, minutes).Establishes good collaboration with Global Clinical Study Manager, Regional Clinical Trial Management Associates, and other key stakeholders globally and regionally.Knowledgeable of clinical study operations, including interpretation and implementation of regulatory and ICH-GCP guidelines.Builds solid knowledge of global clinical trials operations under guidance of the Global Clinical Study Manager.Planning and ExecutionCreates and maintains study-level SharePoint and CST distribution lists.Familiar with study management systems (e.g., eTMF, CTMS) and KPI/Study requirements to ensure compliance and quality standards.Ensures system access is granted and managed appropriately across the study life cycle; supports user account management for systems used in the study.Supports the set-up of the study in relevant trial registries (e.g., ClinicalTrials.gov and others as needed).Supports the development of various study plans.May assist in the review of study-related documents as delegated by the Global Clinical Study Manager (e.g., Clinical Protocols, Informed Consent Forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Case Report Forms (CRFs), CRF Completion Guidelines, and other relevant study plans and charters).Organizes study-specific investigator meetings under the supervision of the Global Clinical Study Manager.Might support the creation and review of site feasibility assessments required for study participation.Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow, and protocol deviations in relevant systems in collaboration with Regional Clinical Trial Management Associates.Understands study operations analysis workflows, methodologies, and related software; able to design, build, and maintain study operations analysis processes ensuring data integrity and traceability.Prepares metrics and updates to key deliverables for management as per information available in relevant systems.May support in the preparation of a study newsletter and other correspondence related to the study conduct (e.g., FAQs, lessons learned) in collaboration with the study team.Supports the TMF specialist with study-level TMF creation and as required maintains the study-level TMF including regular review and QC of TMF documents as per the study TMF QC plan.Supports the Global Clinical Study Manager with study drug forecasts and overall study drug supply activities in collaboration with Global Clinical Supplies.Supports overall data cleaning activities and contributes to the follow-up of outstanding information.Supports the Global Clinical Study Manager with planning and execution of the Clinical Study Report.QualitySupports the identification of operational risks and issues and works with the Global Clinical Study Manager to recommend solutions for discussion with appropriate team leadership.Learns and shares best practices in clinical operations methodologies, systems, and processes with an emphasis on quality and compliance.Suggests improvements to enhance the efficiency and the quality of the work performed on assigned projects.BudgetSupports selection and set-up of vendors for global outsourced activities.Supports management of global study budget including PO set-up.Supports PO set-up for global vendors.Other Qualifications:  Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes.2* or more years of experience in clinical research within biotech, pharma or CRO industry.Fluent written and verbal communication in English.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. General Description Supports the Global Clinical Study Manager in global study delivery and ensures that delegated components of clinical studies are executed to expected and specified quality standards, within timelines and budget. Supports the alignment of study goals with clinical operations goals and objectives under direction of the Global Clinical Study Manager. Demonstrates gSMA leadership capabilities and the ability to influence in a cross-functional collaboration. Strong problem-solving skills with the ability to identify issues proactively and implement effective solutions. Capable of tracking the progress of routine study tasks and ensuring the routine task requirements are met on time. Comfortable adopting and using new software and processes; demonstrates awareness and practical sense for AI applications in clinical operations. Thrives in a fast-paced, dynamic team environment with passion for collaboration and continuous improvement. ​Cross-Functional Leadership Support & Collaboration Supports the Global Clinical Study Manager with the organization and logistics for cross-functional Clinical Study Team (CST) meetings (e.g., agenda, minutes). Establishes good collaboration with Global Clinical Study Manager, Regional Clinical Trial Management Associates, and other key stakeholders globally and regionally. Knowledgeable of clinical study operations, including interpretation and implementation of regulatory and ICH-GCP guidelines. Builds solid knowledge of global clinical trials operations under guidance of the Global Clinical Study Manager. Planning and Execution Creates and maintains study-level SharePoint and CST distribution lists. Familiar with study management systems (e.g., eTMF, CTMS) and KPI/Study requirements to ensure compliance and quality standards. Ensures system access is granted and managed appropriately across the study life cycle; supports user account management for systems used in the study. Supports the set-up of the study in relevant trial registries (e.g., ClinicalTrials.gov and others as needed). Supports the development of various study plans. May assist in the review of study-related documents as delegated by the Global Clinical Study Manager (e.g., Clinical Protocols, Informed Consent Forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Case Report Forms (CRFs), CRF Completion Guidelines, and other relevant study plans and charters). Organizes study-specific investigator meetings under the supervision of the Global Clinical Study Manager. Might support the creation and review of site feasibility assessments required for study participation. Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow, and protocol deviations in relevant systems in collaboration with Regional Clinical Trial Management Associates. Understands study operations analysis workflows, methodologies, and related software; able to design, build, and maintain study operations analysis processes ensuring data integrity and traceability. Prepares metrics and updates to key deliverables for management as per information available in relevant systems. May support in the preparation of a study newsletter and other correspondence related to the study conduct (e.g., FAQs, lessons learned) in collaboration with the study team. Supports the TMF specialist with study-level TMF creation and as required maintains the study-level TMF including regular review and QC of TMF documents as per the study TMF QC plan. Supports the Global Clinical Study Manager with study drug forecasts and overall study drug supply activities in collaboration with Global Clinical Supplies. Supports overall data cleaning activities and contributes to the follow-up of outstanding information. Supports the Global Clinical Study Manager with planning and execution of the Clinical Study Report. Quality Supports the identification of operational risks and issues and works with the Global Clinical Study Manager to recommend solutions for discussion with appropriate team leadership. Learns and shares best practices in clinical operations methodologies, systems, and processes with an emphasis on quality and compliance. Suggests improvements to enhance the efficiency and the quality of the work performed on assigned projects. Budget Supports selection and set-up of vendors for global outsourced activities. Supports management of global study budget including PO set-up. Supports PO set-up for global vendors. Other Qualifications: Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes. 2* or more years of experience in clinical research within biotech, pharma or CRO industry. Fluent written and verbal communication in English. 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