上海招聘

Position Summary
Responsible for ensuring the completeness, accuracy, timeliness, quality and integrity of the Clinical Trial data. Ensure data quality and consistency per applicable regulatory requirements, SOP(s), Processes and data standards. Works with the project team to meet the study objectives. May lead projects per request.

Key Responsibilities
? Ensure all data management activities to be compliance with GCP, relevant regulatory requirements and SOP/WI (work instructions) of dMed and/or Sponsor
? Ensure following and applying CDISC or applicable standard through Clinical Trail.
? Follow and keep compliance with dMed and/or Sponsor SOPs, work instructions to be knowledgeable in applicable sections as bellows, but limited to:
o Create and Maintain Dictionary Coding Conventions
o Setup and perform dictionary coding in clinical trials
o Perform independent QC of coding process
o Managing Medical Dictionaries at function level
? Ensure acknowledge, follow and to be consistent with dMed Policies and procedures
? Update technical skills and knowledge for continuous enhancement of work
? Participate project meetings and contribute to project team delivery

Education and Key Competency Requirements
Professional Experience & Education Requirement
? Degrees in medical / clinical science or life science related disciplines.
? Working experience of clinical development process, understanding CFDA requirements of clinical trials
? Knowledge of clinical trial database and its applications
? Previous experience within a data management role will be preferred
? For Sr Specialist, at least 4+ years experience working on clinical trial database and its applications
? For Project Manager / Manager, no less than 5 years experience in clinical trial database and its applications, plus at least 2 years project leadership experience or as the functional go-to-person.


Key Competency Requirement
? Knowledge of GCP and regulatory requirements of clinical trials
? Knowledge of data management activities and processes
? Work independently with strong customer service orientation
? Effective plan and organize work for delivery within timeline, and able to prioritize to manage multi-tasks
? Attention to details with high quality standards
? Communicate effectively and appropriately with internal & external team including vendors and clients
? Work with project teams to identify and articulate complex problems
? Effective interpersonal skills and collaborative team player
? Effective project management skills

 

 备注： ‘职位月薪’ 仅供参考，具体薪资和福利将根据候选人经验和能力综合评定。

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。