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（助理）临床研究项目管理经理
25-27K/月上海市-上海/本科及以上/3-5年
任女士今天来过
第一三共（中国）投资有限公司
职位详情
岗位职责
岗位职责：
1.确保所负责的研究遵循研究方案、标准程序、公司质量标准和当地法规在计划的时间和预算内完成。
Make sure responsible studies completed within the planned time and budget in accordance with the study plan, SOP, company quality standards and local regulations.
2.确保负责的研究选择合适CRO和其他外部供应商和合适的供应商管理策略，以确保供应商提供高质量的成果。必要时进行现场访视，以确保临床研究的高质量。
Ensure responsible studies selects the appropriate CRO&other vendors and the appropriate vendor management strategy，ensure vendors provide high-quality delivery. Conduct on-site visits when necessary to ensure the high quality of clinical study.
3.确保所负责的研究与全球，ASCA/亚太区团队的沟通，保证全球性和ASCA研究的顺利推进 Ensure responsible studies' communication with the global, ASCA/Asia Pacific teams to ensure the smooth progress of global and ASCA studies.
4.与其他职能部门的顺畅高效合作，统筹研究团队各职能部门解决研究中的问题，定期向相关利益方报告研究进展。
Cooperate with cross functional smoothly and effectively, coordinate the functional team members of the study team to solve the problems in study, and regularly report the study progress to t stakeholders.
5.根据医学部发展策略，协助项目管理科负责人策划推进团队和创新业务的发展计划，推动项目管理团队的绩效改进、运营效率和创新战略。
According to the Medical Division strategy , assist the (associate) director of project manager section in planning and promoting the development plan of the team and innovative business。 Improve the performance, operation efficiency and innovation strategy of the project management team
6.完成直线经理指定的其他工作。
Complete other tasks assigned by the line manager.
资历要求：
1.本科（Prefer硕士）及以上, 医学、药学、生命科学或者相关领域优先
Bachelor's degree (Prefer Master) or above, medicine, pharmacy, life science or related fields are preferred
2.6年以上医药行业工作经验，3年以上大型MNC或跨国CRO临床研究项目管理和团队管理经验
More than 6 years of experience in the pharmaceutical industry, more than 3 years of experience in management and team management of big MNC or multinational CRO clinical studies.
3.熟练掌握监查技能，包括研究开始、进行和研究结束的经验。
Master the monitoring skills, including the start-up, enrolment and close.
4.具备临床试验项目管理经验，优先考虑IV期临床试验、IIS和真实世界研究经验。
Have experience in clinical study project management, prefer phase IV clinical trial experience, e.g., IIS and RWS."
5.掌握GCP/ICH指南、HGRAC和其他适用的监管要求。
Master GCP/ICH guidelines, HGRAC and other applicable regulatory requirements.
6.了解临床试验整体流程、跨部门协作，包括数据管理、医学监查、医学写作、生物统计学流程。
Understand the overall process of clinical study and cross function collaboration, including data management, medical monitor, medical writing, and biostatistics process.
7.较强的沟通和人际交往能力，较强的组织协调和解决问题的能力。
Strong communication and interpersonal skills, and strong ability to organize, coordinate and solve problems.
8.具备多任务多职责管理能力。
Have the ability to manage multiple tasks and responsibilities.
9.熟练掌握MS 办公软件（如Word, Excel, PowerPoint, Outlook）Proficient in MS office software (such as Word, Excel, PowerPoint, Outlook)
1.确保所负责的研究遵循研究方案、标准程序、公司质量标准和当地法规在计划的时间和预算内完成。
Make sure responsible studies completed within the planned time and budget in accordance with the study plan, SOP, company quality standards and local regulations.
2.确保负责的研究选择合适CRO和其他外部供应商和合适的供应商管理策略，以确保供应商提供高质量的成果。必要时进行现场访视，以确保临床研究的高质量。
Ensure responsible studies selects the appropriate CRO&other vendors and the appropriate vendor management strategy，ensure vendors provide high-quality delivery. Conduct on-site visits when necessary to ensure the high quality of clinical study.
3.确保所负责的研究与全球，ASCA/亚太区团队的沟通，保证全球性和ASCA研究的顺利推进 Ensure responsible studies' communication with the global, ASCA/Asia Pacific teams to ensure the smooth progress of global and ASCA studies.
4.与其他职能部门的顺畅高效合作，统筹研究团队各职能部门解决研究中的问题，定期向相关利益方报告研究进展。
Cooperate with cross functional smoothly and effectively, coordinate the functional team members of the study team to solve the problems in study, and regularly report the study progress to t stakeholders.
5.根据医学部发展策略，协助项目管理科负责人策划推进团队和创新业务的发展计划，推动项目管理团队的绩效改进、运营效率和创新战略。
According to the Medical Division strategy , assist the (associate) director of project manager section in planning and promoting the development plan of the team and innovative business。 Improve the performance, operation efficiency and innovation strategy of the project management team
6.完成直线经理指定的其他工作。
Complete other tasks assigned by the line manager.
资历要求：
1.本科（Prefer硕士）及以上, 医学、药学、生命科学或者相关领域优先
Bachelor's degree (Prefer Master) or above, medicine, pharmacy, life science or related fields are preferred
2.6年以上医药行业工作经验，3年以上大型MNC或跨国CRO临床研究项目管理和团队管理经验
More than 6 years of experience in the pharmaceutical industry, more than 3 years of experience in management and team management of big MNC or multinational CRO clinical studies.
3.熟练掌握监查技能，包括研究开始、进行和研究结束的经验。
Master the monitoring skills, including the start-up, enrolment and close.
4.具备临床试验项目管理经验，优先考虑IV期临床试验、IIS和真实世界研究经验。
Have experience in clinical study project management, prefer phase IV clinical trial experience, e.g., IIS and RWS."
5.掌握GCP/ICH指南、HGRAC和其他适用的监管要求。
Master GCP/ICH guidelines, HGRAC and other applicable regulatory requirements.
6.了解临床试验整体流程、跨部门协作，包括数据管理、医学监查、医学写作、生物统计学流程。
Understand the overall process of clinical study and cross function collaboration, including data management, medical monitor, medical writing, and biostatistics process.
7.较强的沟通和人际交往能力，较强的组织协调和解决问题的能力。
Strong communication and interpersonal skills, and strong ability to organize, coordinate and solve problems.
8.具备多任务多职责管理能力。
Have the ability to manage multiple tasks and responsibilities.
9.熟练掌握MS 办公软件（如Word, Excel, PowerPoint, Outlook）Proficient in MS office software (such as Word, Excel, PowerPoint, Outlook)
任职要求
无
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公司信息
第一三共（中国）投资有限公司
- 上海
- 10000人以上
- 生物制药
- 外企
- 无
第一三共致力于通过运用我们全球一流的科学技术，创造新的模态与创新药物，以实现“为提高世界各地人们的生活质量做出贡献”的目标。除了目前的癌症与心血管疾病药物组合外，第一三共还专注于为癌症患者以及其他医疗需求未得到满足的疾病患者开发新疗法。凭借自身120多年的科学专业知识和覆盖20多个国家的业务范围，第一三共及其全球17,000名员工将秉承公司深厚的创新传统，努力实现我们的2030年愿景，成为“为社会可持续发展做出贡献的创新型全球医疗保健公司”。欲了解更多信息，请访问：www.daiichisankyo.com。
