职位概述Position Summary

• 确保临床试验数据的真实性，完整性和准确性。Responsible for ensuring the completeness, quality and integrity of the Clinical Trial data.

• 依据相应法规，标准操作规程，流程和数据标准，确保数据质量和数据一致性。Ensure data quality and consistency according to applicable regulatory requirements, SOP(s), Processes and data standards.

• 与项目团队合作完成工作。Works with the project team to meet the study objectives.

主要职能Key Responsibilities

• 确保数据管理工作符合GCP，相应法规及标准操作规程的要求。Ensure all data management activities to be compliance with GCP, relevant regulatory requirements and SOP/WI(work instructions) of dMed and/or Sponor

• 确保执行CDISC或相适用的数据标准。Ensure following and applying CDISC or applicable standard through Clinical Trail.

• 确保遵守并符合缔脉和/或相关客户SOP流程，主要职能包括但不限于Follow and keep compliance with dMed and/or Sponsor SOPs, work instructions to be knowledgeable in applicable sections as bellows, but limited to:

• 建立和维护医学词典编码指导。Create and Maintain Dictionary Coding Conventions

• 建立试验编码系统，执行医学编码。Setup and perform dictionary coding in clinical trials

• 执行独立质量控制。Perform independent QC of coding process

• 管理医学词典。Managing Medical Dictionaries at function level

• 确保了解、遵守并符合缔脉政策制度(Policy)和流程。Ensure acknowledge, follow and to be consistent with dMed Policies and procedures

学历与工作经验Education & Experience Requirement

• 自然科学，医学，数据管理相关学位或学历。Degrees in a natural/medical science, data management or related discipline.

• 临床试验相关工作经验，了解CFDA的法规要求。Working experience of clinical development process, understanding CFDA requirements of clinical trials

• 临床试验数据及其附属程序的经验。Knowledge of clinical trial database and its applications

• 已有的数据管理工作经验。Previous experience within a data management role will be preferred

Key Competency Requirement

• GCP和临床试验法规相关知识和经验。Knowledge of GCP and regulatory requirements of clinical trials

• 数据管理相关工作经验。Knowledge of data management activities and processes

• 特定情况时，能在有限的指导下独立工作。Work independently, receives instruction primarily on unusual situations

• 完成项目进度，且能在多任务下区分优先级。Work under timeline and priorities of multi-tasks

• 有效且妥善的与内部和外部团队成员合作和沟通，包括供应商和客户。Communicate effectively and appropriately with internal & external team including vendors and clients

• 与项目团队成员共同识别，并解决复杂问题。Work with project teams to identify and articulate complex problems

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。

上班地址：上海市浦东新区祥科路298号佑越国际，3楼301-305