上海招聘

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 procedures

Education & 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 experience

Key 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-tasks

Important 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 situations
candidates through test and interview. 举报 分享

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。