Clinical Data Management Team Lead 上海

月薪： 2-3.5万/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 01-25 发布
  • 五险一金
  • 补充医疗保险
  • 交通补贴
  • 通讯补贴
  • 专业培训
  • 年终奖金
  • 定期体检

职位描述

Position Summary■ Responsible for ensuring the completeness, quality and integrity of the Clinical Trial data.■ Ensure data quality and consistency according to applicable regulatory requirements, SOP(s), Processes and data standards.■ Works with the project team to meet the study objectives.Key Responsibilities- Ensure all data management activities to be compliance with GCP, relevant regulatory requirements and SOP/WI(work instructions) of dMed and/or Sponor- Act as project leader on data management for one or more clinical trials if applicable:- Participate internal functional meetings as required.- Oversee review and report all responding trial and task status as required.- Project monitor and ensure trail deliverables to be in terms of timelines and quality.- To be Sensitive on all identifiable solutions for process and technical issues, Risk management on any data quality deliverables.- Ready to participate in internal/external audits and regulatory inspections- Manage resources and resource projections to ensure project team be consistent with Client needs, expectations and contractual obligations:- Review project tasks and timelines and assign team members- Lead clinical data management project teams in the delivery of services to clients- Ensure staff fulfill their responsibilities in accordance with dMed policies, procedures, SOPs, ICH-GCPs, and other relevant regulatory requirements- Liaise with other functions to ensure consistency of clinical data management approach within the company- Recommend and implement clinical data management performance and productivity improvements to ensure optimal utilization of billable resources.- Perform metrics collection and data analysis to support dMed efforts for continuous improvement in policies, procedures, and business processes.- Identify and implement process improvements through review of clinical data management SOPs, processes; recommend improvement plans to senior management.- Lead task forces to implement process improvement initiatives; Build teamwork and improve process and productivity by working within and across functional areas- Participate in business development initiatives, including presentations and proposal development, Ensure that timely and accurate information is submitted on all proposal efforts- Ensure acknowledge, follow and to be consistent with dMed Policies and proceduresEducation & Experience Requirement- Degrees in a natural/medical science, data management or related discipline- Working experience of clinical development process, understanding CFDA requirements of clinical trials- Previous experience within a data management role, understanding of process including CRF design, database set-up, edit check specification, DMPs and data cleaning activities- Knowledge of clinical trial database and its applications- Project Management, People Management and vendor management experienceKey Competency Requirement- Knowledge of GCP and regulatory requirements of clinical trials- Knowledge of data management activities and processes- Work independently, receives instruction primarily on unusual situations- Work under timeline and priorities of multi-tasksImportant Note: 'Salary range' in the job requirement is just for reference. The salary will be defined after full evaluation of the- Work independently, receives instruction primarily on unusual situationscandidates through test and interview. 职能类别： 医药技术研发管理人员

联系方式

上海 浦东新区 蔡伦路780号6楼Q座

公司信息

全球知名生物医药企业资深研发团队打造的创新服务公司。让你的职场起点更高，更充满挑战和精彩。 我们是谁？     基于中国面向全球制药，生物技术和医疗器械公司的临床开发服务和解决方案提供商:· 临床试验全程及专业领域服务：临床试验设计、数据管理及系统开发、生物统计及编程、运营和项目管理、报告撰写、注册运作和策略、质量保证和稽查、药物安全警戒和风险管理· 战略咨询服务：临床开发和注册策略、研发功能和架构设计、技术支持和国际化支持。 为什么选择我们？ · 缔脉定位于以高品质服务和专业精神成为业界典范。· 缔脉管理层在中国生物医药研发领域耕耘十多年培养了1000+优秀人才。· 缔脉致力于通过系统培训，研发实践和开放式文化培养新一代生物药物研发国际化人才。 创始人及部分核心专业领域创始人 - 谭凌实博士: 拥有20多年跨国一流制药公司总部高级管理经验. 此前担任辉瑞公司全球药物开发运营副总裁, 在中国成功创建了首屈一指的研发中心，且经历10多年发展壮大到多个地点,成为辉瑞全球核心的研发中心之一, 承担药物临床开发,安全风险管理, 注册,临床稽查等关键职能。谭博士多年为RDPAD, DIA 的核心成员，担任重要职务,包括研发委员会主席, 全球董事等。谭博士还带头建立了与国内一流高校的教育培训合作,比如复旦大学, 北京大学，交通大学. 培养了不少拥有专业技能和行业知识的临床数据管理和编程人才.谭博士有在美国建立初创企业的经验, 且在美国一流制药企业研发中心工作多年. 谭博士拥有生物统计博士学位。

上海相关职位
猎才二维码