Syneos FSP Clinical Quality Manager 临床质量管理
保存此职位并让您的搜索井井有条
创建一个免费帐户来保存职位、创建警报并从仪表板返回此列表。
Location:
北京朝阳区五矿广场/上海静安寺中信泰富 （北京优先） Position title: Clinical Quality Manager 临床质量管理经理 招聘要求
- 统招本科及以上学历
- 1年以上临床质量管理经验，如流程管理，风险管理；具备体系化 的质量管理思路；global CRO/pharma工作经验优先
- 有多种vendor管理经验（包括lab vendor) 优先
- 了解当地法规要求，具有CFDI/FDA等核查经验优先
- 良好的沟通能力和执行能力，能有效的与跨职能团队合作，流利的英文听说读写能力 Responsibilities
- Act as a point-of-contact (POC) and subject matter expert (SME) for clinical quality requirements and activities in China for assigned portfolios, studies, or vendors.
- Implement strategies and activities related to inspection readiness and audit response management for clinical development conducted in China.
- Lead the development of Risk/Quality Plans for Development China functions and the China clinical trial portfolio and associated key vendors when needed.
- Support GCP quality event reporting, assessment, investigation, and remediation activities for GCP quality issues related to China clinical development activities.
- Develop and deliver GCP quality relevant training as needed
Requirements:
- A scientific or technical degree; an advanced degree (MS/MD/PhD) is preferred.
- Extensive clinical development and business experience that demonstrates a thorough understanding of the processes associated with clinical and regulatory operations.
- Knowledge of local and international regulatory requirements, especially intensive experience in CFDI/FDA Inspection.
- At least 5 years of increasingly responsible positions in Clinical Operation and/or Clinical Development Quality.
-
FSP-临床项目经理（Global）-北京
1 week ago
Beijing, Beijing, 11, 中国 ClinChoice昆翎 全职 ¥300,000 - ¥540,000 合同该职位来源于猎聘 此岗位为FSP-MNC申办方，要求3年及以上PM经验，Global 背景 主要负责Global 大临床肿瘤、非肿项目，英文书面Workable 福利、培训叠加享受CRO+申办方双重福利 1）日常弹性工作制，不打卡 2）六险一金、年终奖、带薪假期、晋升完善
-
IP质量管理
1 week ago
Beijing, Beijing, 11, 中国 众能联合数字技术有限公司 全职 ¥132,000 - ¥216,000 合同该职位来源于猎聘 岗位职责： 1、负责三方IP相关供应商的技术能力调研，持续完成各三方IP供应商的策略管理、优化IP的license及Roytal费用支出； 2、协同采购部门，完成公司三方IP供应商的三方NDA签署、账号管理、合规审核、合约框架拟定，合约签署；
-
Beijing, Beijing, 中国 爱恩康临床医学研究(北京)有限公司 全职 ¥8,000 - ¥18,000 临时该职位来源于猎聘 Working fully outsourced at one of our global pharmaceuticalclients, the Clinical Trial Assistant plays a fundamental role in thesuccessful execution of global clinical trials. Operating within the scope ofthe Clinical Development Plan, ICH-GCP guidelines and in accordance with thestudy protocol, local and international regulatory...
-
Syneos FSP Sr Project Manager 高级临床项目经理
2 weeks ago
Beijing, Beijing, 中国 赛纽仕医药咨询(上海)有限公司 全职 ¥40,000 - ¥55,000 临时该职位来源于猎聘 Clinical Project Manager (SPM role), FSP Top Global Pharma 工作地点：上海/北京office based 上海市静安区南京西路1168号中信泰富广场 北京市朝阳门北大街五矿广场B座9层 项目领域：global II/III期肿瘤/非肿瘤/疫苗不同领域 招聘要求：...
-
Beijing, Beijing, 中国 梅赛德斯-奔驰租赁有限公司 全职 ¥15,000 - ¥30,000 临时该职位来源于猎聘 Tasks Continuously develop and update QM ADAS release methodology including validation strategy and release KPI, process and tools to meet major use cases in China market, focus on market specific usage environment, conditions and user habit, to evaluate and approve the quality and performance of ADAS functions in China in accordance...
-
Beijing, Beijing, 中国 赛纽仕医药咨询(上海)有限公司 全职 ¥30,000 - ¥40,000 临时该职位来源于猎聘 FSP Global Pharma 地点: 上海/北京 招聘要求： 博士学历, 可接受完成医院规培的应届，prefer有医院+企业经验，英语流利 工作地址： 上海市浦东新区张江科学城中科路1699号上海科技投资大厦9层 北京市朝阳门北大街五矿广场B座9层 公司提供丰厚的薪资福利:
-
Site Contracts Lead/临床合同管理
2 weeks ago
Beijing, Beijing, 中国 赛纽仕医药咨询(上海)有限公司 全职 ¥25,000 - ¥35,000 临时该职位来源于猎聘 Job Summary Manages negotiation of clinical study agreements (CTAs) on a study level and drives CTA document finalization and execution, including contractual language & terms, financial attachments, and investigator grant budgets in collaboration with a global team of site contract negotiators for Site Contracts Service Center for...
-
临床项目管理（SPM）
3 weeks ago
Beijing, Beijing, 中国 上海赛科利汽车模具技术应用有限公司 全职 ¥20,000 - ¥35,000 临时该职位来源于猎聘 岗位职责： 1、全面负责试验项目的管理、督导，并按时完成临床试验工作； 2、负责研究单位的调研筛选、协议谈判，召开临床试验各阶段会议； 3、培训指导各有关工作人员，保证临床试验顺利进行；...
-
Quality Management EE PLQ OTA_OTA项目质量管理工程师
3 weeks ago
Beijing, 中国 Mercedes-Benz Group China 全职TasksContinuously develop and update QM OTA release methodology including validation strategy and release KPI, process and tools to meet major use cases in China market, focus on market specific usage environment, conditions and user habit, to evaluate and approve the quality and performance of OTA rollout in China in accordance to strategic Projects.Conduct...
-
Quality Management EE PLQ MBOS_MB.OS项目质量管理工程师
3 weeks ago
Beijing, 中国 Mercedes-Benz Group China 全职TasksEstablish and maintain the PLQ MB.OS role for China and cooperate with PLQ Tech. in China through alignment and exchange with HQ counterparts:Exchange content regarding key necessary processes with HQ PLQ MB.OS.Monitor HQ decision making progress and conclusion for issues also impact PbP carlines with HQ PLQ Tech and PLQ MB.OS.Track progress of EE...
