临床项目经理 上海

月薪： 30-50万/年

该公司所有职位
  • 5-7年经验
  • 本科
  • 招2人
  • 03-08 发布
  • 五险一金
  • 餐饮补贴
  • 专业培训
  • 绩效奖金
  • 年终奖金
  • 定期体检
  • 股票期权

职位描述

Act as a key contact for Project(s) Manage and communicate with multi-functional teams on regional or global interdisciplinary projects/studies to ensure on-time, and within budget deliverables for projectsManage clinical projects to meet Company requirements and satisfaction. This includes managing resources, budgets, milestones, timeline and qualityPlan, initiate, develop and organize clinical trials in accordance to the highest standards required in the good clinical practices, regulatory obligations, investigator integrity and compliance with study protocols and proceduresSet up , maintain, execute and implement project-related documents, dossiers and files, project databases, project timelines and processes, as well as tracking systems or other tracking/analysis tools for ManagementReview, finalize and approve all study-related regulatory and administrative documents (including investigator study budgets and contracts) from investigator sites, monthly vendors/site invoices, monthly monitoring reports, work progression reports and other documentsPlan and coordinate in regular study team meetings and present at the Investigator’s meetings , site initiation meetings and/or site close-out meetingsAssess project resource requirements on a continual basis to ensure appropriate resources are allocatedIdentify specific training needs and supervise, train and mentor project team/clinical research staff within the company on project related policies, procedures, project management tracking tools, and other relevant SOPsWork closely with CRO to oversee the implementation of project specific procedures and requirements to ensure that the study goals and expectations (on-time, on-budget, quality performances) are metMeasure and keep track team overall performance indices against projected baselines, timeline and milestones to ensure that all project work are completed and delivered to company’s requirements and satisfactionsResolve and recommend solutions and manage any deviation from plan or budget 任职要求：Bachelor degree, major in nursing, pharmacy or other science-related background from a recognized institution, and/or equivalent combination of training and experiencel Minimum 4 years’ experience in clinical research, preferably with be familiar with oncology clinical research. Advance knowledge of ICH-GCP guidelines, local GCP guidelines and regulations in the regionFundamental understanding of cross-functional processes, clinical trial processes and the regulatory environmentsGood computer/technology skills including MS Word, MS Excel, and PowerPointEffective written and verbal communication skills, preferably with good command of English in addition to local languagePossess good organizational and interpersonal skillsAbility to manage time and work independentlyHigh integrity in personality and professionalismPositive attitude, high degree of initiative and committedSelf-initiative to perform duties, with good analytical and problem-solving capabilitiesAbility to handle multiple tasks and expected to follow through with completion of assigned tasks with minimal supervisionMeticulous and able to work in a fast-paced environmentAble to work under pressure 职能类别： 医药学术推广

联系方式

银都路388号B座

公司信息

科济生物医药（上海）有限公司成立于2014年10月，是中国首家专注于CAR-T细胞免疫治疗的创新型企业，也是全球知名的实体肿瘤CAR-T细胞治疗研发企业。 秉承“科学创造，济世救人”的价值观，科济生物建立了高效的管理、研发、生产团队。公司现有员工130多人，硕士及博士学历员工占65%左右，拥有多名来自辉瑞、罗氏等全球顶尖生物医药公司的高管及研发人员。 科济生物拥有一大批具有自主知识产权的技术储备。公司拥有包括第四代CAR-T技术在内的八十多项国内外专利技术，自主构建了研发肿瘤靶向抗体的的全人抗体库与人源化抗体技术平台，自主研发了能够覆盖大部分实体瘤及血液肿瘤的高效特异性CAR-T等候选产品。 科济生物开展了针对GPC3、EGFR/EGFR VIII 、Claudin18.2等靶点的全球首创的实体瘤CAR-T临床试验，多个项目获得了新药创制国家十三五重大专项支持。科济生物于2017年6月公布了全球首个肝癌CAR-T临床一期数据：在接受治疗的13名肝癌患者中，无任何患者出现严重毒性（3级或4级）。截止到2017年8月，已有2名肝癌晚期癌症病人的生存期已超过24个月。 展望未来，作为拥有全球影响力的业内标杆，科济生物将始终坚持“科创济世”的宗旨，矢志不渝、持续创新，积极拓展海外市场，加速国际化进程，大力推进与国际顶尖研究机构、知名医院合作，在国内及海外开展更多肿瘤靶点及适应症的研究，努力将细胞免疫治疗技术推向肿瘤临床治疗，造福更多患者。 公司大事记 2014.10----科济生物医药（上海）有限公司成立（上海聚科生物园区） 2014.11----完成A轮融资(1000万人民币) 2015.05----开展全球领先的脑胶质瘤CAR-T临床试验 2015.06----开展全球首个针对肝细胞癌的CAR-T临床试验 2015.09----达成与上海市肿瘤研究所战略合作协议 2015.10----ESOP平台上海科集投资管理合伙企业（有限合伙）设立 2016.01----完成B轮融资(3000万美元，估值1.73亿美元) 2016.04----完成香港子公司注册 2016.05----完成美国子公司注册 2016.08----公司ESOP首次授予管理团队及核心员工激励股权 2016.09----上海制备中心开始施工 2017.03----上海GMP细胞制备中心进入调试阶段 2017.05----启动全球首个Claudin18.2临床研究用于治疗胃癌、胰腺癌 2017.06----ASCO年会上公布肝癌CAR-T项目临床一期数据

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