北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京生物工程/生物制药招聘

Clinical Data Manager临床数据管理

盈帆达医药咨询(上海)有限公司

  • 公司规模:10000人以上
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2020-03-18
  • 工作地点:北京-朝阳区
  • 工作经验:招若干人
  • 学历要求:03-16发布
  • 语言要求:不限
  • 职位月薪:1.5-2万/月
  • 职位类别:生物工程/生物制药  临床数据分析员

职位描述

JOB SUMMARY This position is responsible for assisting in all clinical data management activities required for clinical trials with proficiency and by providing guidance to other Clinical Data Associates (CDAs). 


JOB RESPONSIBILITIES


  • Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s).
  • Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).
  • Creates and enters test data for User Acceptance Testing (UAT)
  • Performs User Acceptance Testing (UAT) for data entry screens, edits and assigned data review listings, all different roles used in the study.
  • Receives and enters lab normal ranges.
  • Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets.
  • Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections in cases where queries are not required, per the Data Validation Specification (DVS) and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries correctly and re-queries where appropriate.
  • For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the Case Report Forms (CRFs) and database accordingly. Submits copies of the DCFs to sponsors as necessary.
  • For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies.
  • For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.
  • For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable electronic data capture (EDC) systems.
  • Creates electronic storage media per SOPs for Electronic Data Capture (EDC) studies.
  • Participates in internal meetings and internal/external audits as required.
  • Files documentation in the Data Management Study File (DMSF).
  • Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College).
  • Creates and enters test data for Standard Data Tabulation Model (SDTM) test data.
  • Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs.
  • May coordinate the work of CDAs assigned to the project.
  • May provide training on data management activities and systems.
  • Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party.
  • Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries.
  • Runs data cleaning and/or status reports.
  • Performs Serious Adverse Event (SAE) reconciliations.
  • Understands the coding process.
  • Understands the purpose of interim, dry run, data cut.

QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’)

  • BA/BS degree in the biological sciences or related disciplines in the natural science/health care field.
  • Experience with DM practices and relational database management software systems preferred.
  • Oracle Clinical, Rave, or Inform systems preferred. Knowledge of clinical data, and ICH/Good Clinical Practices. Knowledge of medical terminology preferred.
  • Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications. Excellent speed and accuracy of keyboard skills.
  • Work experience in clinical research, drug development, data management, or other healthcare environment preferred.
  • Familiarity with medical terminology.
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
  • Good organizational, planning, and time management skills preferred. Ability to multitask under tight deadlines while providing attention to detail. Ability to be flexible and adapt to change. Ability to work independently as well as part of a multi-disciplinary team.
  • Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management. Minimal travel may be required (up to 25%).

公司介绍

Why Syneos HealthTM? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.

联系方式

  • Email:claire.liu@inventivhealth.com
  • 公司地址:地址:span国贸银泰C座