职位&公司对比

招聘中

临床数据管理员

-K·薪
  • 生物/制药
  • A轮
招聘中

Data Manager

-K·薪
某知名医疗健康上市公司

职位详情

  • 上海
  • 3-5年
  • 本科
  • 医学相关专业
  • 临床工作经验
  • 医药相关专业
  • 临床数据管理

岗位职责: 1. 撰写/审阅数据管理计划(DMP)、数据核查计划(DVP)、数据管理报告(DMR)、数据录入指南(CCG)等数据管理文件,并负责对数据文件进行保存、更新和存档。 2. 设计/审阅病例报告表(CRF/eCRF),并对数据库进行用户接收测boss试(UAT),保障数据库及时上线发布。 3. 在项目实施过程中对试验数据进行核查,对可疑数据提出或发布质疑,跟踪、监督、BOSS直聘解决问题数据,完成数据库锁定前的数据质控工作。 4. 撰写/审阅严重不良事件一致性核查计划,进行严重不良事件一致性核查。 5. 完成/审阅医学编码。 6. 撰写/审阅外部数据传输协议,执行外部数据一致性核查。 7. 撰写/审阅数据核查直聘报告及数据审核会议需要使用的资料,并按要求参与数据审核会议。 8. 参与审阅方案偏离计划及方案偏离列表。 9. 联络、监督、管理外部数据供应商,保证外部供应商数据管理工作按公司要求的质量及进度开展。 10. 完成公司指定的其他工作。 任职资格: 1. 学历:本科以上学历,医药、卫生、临床、护理,信息/计算机等相关专业。 2. 工作经验/行业经验/本岗位经验:制药企业或CRO公司3年以上相关工作经验,有肿瘤/非肿瘤临床数据管理工作经验者boss优先考虑。 3. 知识/技能:了解《药品管理法》、《新药审批办法》,了解ICH-GCP,了解药物研发的全过程,熟悉临床试验全过程以及数据管理全流程。 4. 外语程度:英语水平至少达到CET4。 5. 计算来自BOSS直聘机能力:掌握电脑的基础知识,能熟练操作中英文操作系统,熟练掌握办公自动化软件的应用,有临床电子数据采集系统(EDC)使用经验者优先。 6. 出差频率: 较少 7. 其它:工作认真细致有耐心,责任心强,良好地沟通和团队协作能力。

职位详情

  • 上海
  • 1-3年
  • 本科
  • DM
  • 临床数据管理

The Position You will work as a DATA MANAGER in the Portfolio Delivery Pods within Data Strategy and Delivery in PD Data Sciences and with a team of experts in data life-cycle management who acquire and curate data for use in exploratory research, clinical development and evidence generation. You will collaborate with peers within the function and across the organisation to identify, design and execute fit for purpose data management solutions, adhering to F.A.I.R. (Findable, Accessible, Interoperable, Reusable) principles. You will ensure the timely completion of data management deliverables and partner with Exkanzhunternal Business Partners (ExBPs) and vendors, overseeing and providing technical expertise in the delivery of high quality data. You may also contribute to functional, cross functional, enterprise-wide or external initiativ来自BOSS直聘es that shape our technical landscape, business and healthcare environments. You will need strong strategic, collaboration and communication skills, as well as an entrepreneurial mindset, to evolve the way we collect and deliver data and to develop and deliver medicines for our patients. In this role you will: Collaborate with peers within the function and across the organisation to identify, design and execute fit for purpose data management solutions, ensuring adherence to FAIR principles Act as experts for data collection and acquisition, advising teams and stakeholders on best practices and proposing innovative solutions. e.g. the collection of new data types (e.g. emergent biomarkers), new technologies (e.g. sensors), and new data sources (e.g. RWD, EMR) Partner with and provide oversight of data management deliverables including non-CRF data quality to our External Business Partners (ExBPs) and vendors. Provide Quality Assurance on tasks as applicable to ensure a high quality of data and compliance with applicable pharma industry regulations and standards Proactively manage timelines and track decisions, ensuring successful delivery of the study work packages carried out at ExBPs. Continue to be accountable for quality and where needed,kanzhun provide support in the form of business and technical expertise to our ExBPs As required, be the Data Sciences rep on the SLT triad and any associated meetings such as Data Quality meetings. At a minimum, act as the DSD rep for Data Sciences and Study Teams and proactively engage with stakeholders across the business to understand their needs and influence their understanding of decisions made on our function You are someone who brings: BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics OR equivalent industry experience.
 Demonstrated leadership capabilities around decision-making, negotiation, motivation (self and others) and influencing Demonstrated entrepreneurial mindset and self-direction, ability to mentor others and willingnBOSS直聘ess to learn new techniques Knowledge of biological principles, display interest and demonstrate scientific curiosity including an understanding of data types and their scientific use (clinical, biomarker, WGS, RNA-seq, etc.) A minimum of 3 years experience in a Data Management role Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, cubossriosity and diversity. Roche is an Equal Opportunity Employer.

技能解析

专有技能
  • 数据管理
  • 计算机能力
  • 办公自动化
  • 管理文件
  • 解决问题
  • 外部供应商
  • 临床试验
  • 项目实施
  • 管理工作经验
  • 管理工作
  • 传输协议
  • 办公自动化软件
  • 协作能力
  • 团队协作
  • 团队协作能力
  • 英语水平
  • 数据采集

    数据来自CSL职业科学研究室

    技能解析

      暂无识别出相关技能要求

      工作时间

      上午08:30   -   下午05:30

      公司福利

      • 五险一金
      • 补充医疗保险
      • 定期体检
      • 年终奖
      • 保底工资
      • 企业年金
      • 工龄奖
      • 带薪年假
      • 员工旅游
      • 餐补
      • 零食下午茶
      • 团建聚餐
      • 通讯补贴
      • 高温补贴
      • 节日福利
      • 生日福利

      备注

      职位发布者未明确表明公司信息,具体可咨询职位发布人进行确认。

      更新于 2025-03-11