Data Management - Coder 上海

月薪： 1-2.5万/月

该公司所有职位
  • 2年经验
  • 本科
  • 招1人
  • 03-04 发布
  • 专业培训
  • 五险一金
  • 补充医疗保险
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 定期体检
  • 弹性工作
  • 年终奖金

职位描述

Requirements Executes Data Management coding functions in accordance with PPC and/or Sponsor Standard Operating Procedures (SOPs), guidelines, and global standards, maintain coding integrity and ensure consistency across all projects and also collaborates with Data Management CDA to ensure timely completion of coding tasks. ResponsibilityPerform coding using web-enabled dictionary and coding management system (e.g. OC TMS or ds Navigator) or other system as required. Perform Coding in accordance with study specific coding conventions as outlined in the Data Management Plan (DMP) for assigned projects. Ensure Sponsor specifications for coded data are met and be responsible for receiving or sending reports/spreadsheets of coded data.Perform coding using MedDRA and WHO Drug or other Sponsor specified dictionaries. Perform coding tasks relevant to PPC and/or Sponsor SOPs, ICH or other regulatory guidelines in Data Management. Collaborate with Data Management CDA to ensure coding consistency, completeness and accuracy of assigned coding projects. Works in a timely manner in accordance with all the activities specified in the DMP under supervision and guidance of the Lead Data Manager. Responsible for overall review of coding domain set-up, review of hierarchy of external dictionaries for ability to utilize and code effectively, and prepare coding reports / spreadsheets to send to the Sponsor, for assigned projects. Provide mentoring and feedback for new staff Manages time effectively in order to produce a quality deliverable in expected timeframe.Anticipates changing priorities and demands and addresses them proactively. Perform other duties as required by the Department. qualifications and experienceMedical (preferred) or Pharmacy/Nursing or Life Science degree and relevant experienceMinimum 2 years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job Ability to maintain confidentiality of data and information during interactions with staff at all levels Accurate keyboarding skills Understanding of medical terminology Understanding of ICH-GCP principles Proven related Coding experience using multiple dictionaries such as Med DRA and WHO Drug 职能类别： 医药技术研发管理人员 医药技术研发人员 关键字： 医学编码 Coder

联系方式

黄陂南路（地址1号线新天地站，9、10、13号线马当路站）

公司信息

PPC佳生（Protech PharmaservicesCorporation）成立于1997年，致力于为国内外制药企业及生物技术公司提供专业化临床研究服务，为中国大陆、中国台湾、韩国以及日本等亚太地区客户提供临床试验及生物样本检测分析服务。自1997年至今，自成立以来，PPC佳生已为来自全球范围客户完成了2000多个早期临床研究项目（包含新药I期PK、仿制药BA/BE以及生物类似药PK/PD）；并且还执行了超过400个新药后期临床试验项目；所执行的研究方案涵盖24个疾病治疗领域。目前是亚太区域唯一通过日本PMDA、欧盟ANSM、东盟NCPB以及美国FDA核查的临床基地，生物样品实验室开发约300种药品分析方法，以丰富的执行经验提供海内外客户优质服务。2012年，PPC佳生于台北（McKay memorial Hospital）建立了第一家下属I期临床试验中心，并于2016年作为主要投资方与徐州医科大学资源共享，优势互补联合组建合作共同建立了徐州医科大学附属医院I期药物临床试验中心。

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