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《财富》世界500强赛诺菲定于11月29日进行招聘
时间: 2017-11-23 14:57  来源: 计算机学院

 招聘时间:2017年11月29日 15:00

招聘地点:望江基础教学楼B318

 

2016年《财富》世界500强榜单,233名

 

 

赛诺菲是一家全球领先的医药健康企业,专注患者需求,致力于研究、开发、生产并推广创新的治疗方案!

拥有五大全球事业部:糖尿病与心血管疾病、普药新兴市场、赛诺菲健赞、赛诺菲巴斯德和健康药业

10万余名员工,遍及100多个国家

2016年净销售额达338.21亿欧元

38个国家设有87家工厂

 

赛诺菲集团

 

赛诺菲是一家全球领先的医药健康企业,专注患者需求,致力于研究、开发、生产并推广创新的治疗方案。

赛诺菲拥有五大全球事业部:糖尿病与心血管疾病、普药与新兴市场、赛诺菲健赞、赛诺菲巴斯德和健康药业。赛诺菲共有10万余名员工,遍及100多个国家,并在38个国家设有87家工厂。

 

赛诺菲中国

 

赛诺菲一直以来秉承对中国的承诺。1982年,赛诺菲在中国开设办事处,跻身首批进入中国的跨国制药企业。赛诺菲目前在中国约有9,000名员工,是国内增长最快的医药健康企业之一。

 

赛诺菲官网www.sanofigenzyme.com

 

 

 

 

 

JOB DESCRIPTION  1

Clinical Data Coordinator

 

Job Title: Clinical Data Coordinator临床数据管理员

Department: Trial Operations - Data Management试运行-数据管理

Numbers: 15

Location: Chengdu成都高新区

Salary8000-10000(本科研究生),12000(博士)年终奖20%,全医疗保险,五险一金

 

Job Summary工作概要

 

The Clinical Data Coordinator (CDC) is responsible for routine data management activities during the course of a study under the supervision of study lead, such as data review, validation, cleaning and tracking, as well as maintaining data management documents if needed.

临床数据协调员(CDC)负责在研究指导下进行日常的数据管理活动,如数据审查、确认、清理和跟踪,以及在需要时维护数据管理文件。

 

Key Accountabilities主要职责

 

· Performs data cleaning tasks following standard processes (e.g., manages queries, including data validation and date review, performing quality checks).

按照标准流程执行数据清理任务(例如,管理查询,包括数据验证和日期审查,执行质量检查)

· Monitors the progress of data cleaning activities and the quality of the data; gives regular feedback and status reports to the SDM or study team.

监测数据清理活动和数据质量的进展情况;向SDM或研究小组提供定期反馈和状态报告。

· Deputizes for the SDM, when appropriate; may liaise directly with internal and external partners.

如需要可代表SDM,直接与内外部合作商联系。

· Participates if needed in the development of protocols, CRFs, edit checks, Data Management related documents (data management plan, centralized moniroting paln, reconciliation plan, data Validation Plan and Data Review Report/listing, etc.) as per company standards; may be involved in the test of the database.

需按照公司标准化流程参与相关条款拟定、编辑审查、管理相关数据文件(数据管理计划,集中监控,协调,数据验证和数据审查报告/列表等); 可能涉及数据库的测试

· Continually contributes to the evaluation of CDM processes for improvements.

持续促进CDM流程改进的评估

Education and Qualifications教育和资格

 

 Bachelor degree or above

本科及以上学位

 Preferably in a life science or mathematics-related area (e.g., computer sciences)

最好在生命科学或数学相关领域(例如,计算机科学)

 With or wihtout Clinical Data Management experience

不要求具有临床数据管理经验,有相关经验尤佳。

 

Knowledge and Skill Requirements知识和技能要求

 

· Basic knowledge of clinical trial development process.

具备临床试验开发过程的基本知识

· Ability to foster a good communication and collaboration within CDM and with clinical study teams.

能够促进CDM和临床研究团队之间良好的沟通和协作。

· Demonstrates flexibility through effective negotiations.

通过有效谈判显示灵活性

· Ability to follow study timelines and implementation plans while paying attention to details.

关注学习时间表和执行计划的能力,同时注重细节

· Able to acquire and apply new technical skills.

能够获得和应用新的技术技能

· Proactive work attitude and works well under pressure.

积极主动的工作态度,能承受工作压力。

· Good team player.

良好的团队合作精神

· Good English skills (both verbal and written).

良好的英语技能(口头和书面)

· Proficiency in Microsoft Office Suite (intermediate level)

熟练掌握微软办公套件(中级)

 

 

 

JOB DESCRIPTION  2

Data Scientist

Job Title: Data Scientist数据研究员

Department: Risk BasedMonitoring 风控监测

Numbers: 2

Location: Chengdu成都高新区

Salary8000-10000(本科研究生),12000(博士)年终奖20%,全医疗保险,五险一金

JOB PURPOSE工作目的

The RBM data scientist will be responsible for preparing the data and running the necessary analyses, from operational and clinical databases SAS, using mainly the CluePoints software but potentially doing more data exploration on SAS, to help the study teams implement and adjust their RBM strategy as the studies are progressing.

 

在研究进行过程中,基于风险的监测数据研究员将会从临床数据库SAS中主要使用CluePoints软件准备数据并进行必要的分析,但可能在SAS上进行更多的数据探索,帮助研究团队实施和调整基于风险的监测

 

KEY ACCOUNTABILITIES主要职责:

The RBM data scientist will more precisely基于风险的监测数据研究员将更精确:

- Identify the data sources and propose a data preparation approach , eg using sdtm data sets as an entry

确定数据源,提出一个数据准备方法,例如使用SDTM数据集作为输入

- Identifying, selecting, possibly combining the key variables

识别、选择、可能合并关键变量

- Preparing the datasets needed

准备所需的数据集

- Run Cluepoints reports (KRI, DQA) on a regular basis in accordance the study specificities

根据定期研究特异性定期运行cluepoints报告(KRIDQA

- Run additional analyses, in conjunction with B&P/TO teams to understand findings if appropriate

在适当的情况下,与团队一起进行额外的分析,以了解调查结果。

- Provide elements of interpretation of findings to the RBM central monitors to understand the signals 

提供研究结果的解释元素的RBM中央监视器了解信号

- Prepare written report summarizing results (data findings and signals identified), if needed 

编写书面报告,总结结果(如发现数据和信号)

- Support the definition of actions to be taken to adapt the RBM strategy to signals

支持将要采取的行动,以适应国际战略信号的定义

- Closely collaborate with RBM Central Monitor

RBM中央监控密切合作

- Follow RBM processes defined for the global and local team

  遵循RBM过程的全局和局部的团队定义

- Provide mentoring to new RBM Data Scientist

  提供指导新的RBM数据研究员

 

JOB-HOLDER ENTRY REQUIREMENTS  job-holder入学要求:

Education教育类:

A scientific or biomedical bachelor degree and above or equivalent

学士或以上学位或同等学历

Experience & knowledge经验与知识:  

- 2+ years’ experience in a Clinical Research environment (CRO or Pharma)

2年以上临床研究工作经验(CRO或制药)

- Experience in clinical data programming (SAS, R …)

临床数据编程经验(SASR…)

- Familiar with the notions of protocol and an annotated CRF

熟悉协议和注释CRF的概念

- Able to understand, transform and analyze clinical databases coming from Phase I through Phase IV studies in multiple therapeutic areas

能够理解、转换和分析来自第一阶段的临床数据库,通过多个治疗领域的第四阶段研究

- Able to interpret and explain atypical patterns in the clinical and operational data

能够解释和解释临床和手术数据中的非典型模式

- Experience with CDISC databases is a plus

与不同的数据库经验者优先

 

Core competencies核心竞争力:

- Good English oral and written communication skills

良好的英语口语和书面沟通能力

- High degree of accuracy and attention to detail is required

高度的准确性和对细节的关注是必需的

 

The RBM data scientist must have data analytical skills, fluent in SAS programming, have a good understanding of statistical concepts to interpret findings and graphs provided by CluePoints, a good understanding of data flow, and good communication skills to translate those finding into clear messages to the study team.

基于风险的监测数据研究员必须具备数据分析能力,SAS编程流利,有很好的理解统计的概念来解释所提供的cluepoints结果和图表,了解数据流,和良好的沟通技巧,将这些发现转化为清晰的信息传递给研发团队。

 

JOB DESCRIPTION  3

Statistical Programmer

Job Title: Statistical Programmer统计程序师

Numbers: 15

Location: Chengdu成都高新区

Salary8000-10000(本科研究生),12000(博士)年终奖20%,全医疗保险,五险一金

JOB PURPOSE工作目的:

Provides timely support to the study on all programming matters according to the global project strategies.

根据全球项目战略,及时支持对所有规划事项的研究

 

KEY ACCOUNTABILITIES主要职责:

Performs programming activities for statistical deliverables within a study/project, eg. DRSR, CSR, CTD, DSUR, etc

执行规划活动统计成果在研究、eg. DRSRCSRCTDDSUR,等.

Performs quality control, as required per SOPs, for statistical programming deliverables (including input in Validation Plan & QC documentation).

根据标准操作程序的要求,对统计程序的可交付成果(包括验证计划和质量控制文件中的输入)进行质量控制。

Provides items required for e-submission (i.e. SAS transport files, define.pdf, annotated CRF).

提供所需的电子提交的项目(即SAS传输文件,define.pdf,注释CRF

Performs ad-hoc and explortary analysis as request.

执行临时和explortary分析要求

 

JOB-HOLDER ENTRY REQUIREMENTS job-holder入学要求:

Education:

Bachelor or master degree in statistics, computer science, or relevant filed

统计学、计算机科学或相关领域的学士或硕士学位

 

Experience & knowledge:  

Min 1 yr. SAS programming experience in clinical trial development.

1年,SAS编程经验在临床试验的发展

Good SAS programming skill required.

SAS编程技能要求

 

Core competencies核心竞争力: 

Effective English verbal and written communication skills in relating to colleagues and associates both inside and outside the organization control approach to work.

有效的口头和书面英语沟通能力与同事组织内部和外部控制的工作方式

Ability to work effectively in a multi-cultural context as a good team member.

能够在多元文化背景下的一个很好的团队成员有效地工作

 

 

JOB DESCRIPTION  4

Clinical Trial Master File (TMF) Document Specialist

Job Title: TMF Document Specialist 临床试验文档专员

Numbers: 3

Location: Chengdu成都高新区

Salary8000-10000(本科研究生),12000(博士)年终奖20%,全医疗保险,五险一金

 

JOB PURPOSE工作目的:

The TMF Document Specialist is responsible for preparing临床试验文档专员负责准备:

Filling and archiving of clinical trial documents including CRFs and all documents related to the Clinical Trial Master File (TMF)

CRF and related clinical documents for submission

CD roms for the investigator study file

He/she works in strong collaboration with TMF manager

填写和存档临床试验文件,包括CRF和与临床试验主文件相关的所有文件提交CRF和相关临床文件

提交相关的临床文件

 

PRINCIPAL DUTIES AND RESPONSIBILITIES主要职责:

 

He/she works in close collaboration with study team to provide services for trial record management, from study set-up to closure. These records include CRFs and all documents for the clinical trial master file.  

团队合作,能够融入团队并妥善管理CFR和所有其他实验数据。

 

Perform daily tasks associated with initial receipt and quality control of clinical trial documents for filling and archiving.

完成与初始数据和临床试验数据文档质量管控相关的日常任务。

 

He/She involved in the preparation of the Clinical Study Report (CSR) appendices into the document repository system.

将临床研究报告(CSR)附录编写到文档库系统

 

Assist in the preparation and QC of documents for submission to regulatory agencies.

参与准备工作,并将QC文件提交监管机构

 

 Perform the data entry in archiving tools for the tracking of all documents

将数据登记在归档工具中,以便文档追踪

 

 Perform QC and all supportive activities on the preparation of CD rom for the Investigator Study File.

为研究者准备文件光盘并参与QC和其他所有准备工作

 

 He/she communicate effectively with study teams

善于沟通交流

 

COMPLEXITY & PROBLEM SOLVING复杂性与问题解决:

A. Major Challenges/Problems主要挑战/问题:

To perform quality control on documentation on an ongoing basis during the clinical trial course and be able to collect documentation on time for submission or inspection and for the site closure visit.

在临床试验过程中不断地对文件进行质量控制,并能及时收集提交或检验的文件,并对现场关闭进行访问

B. Key Internal and External Relationships关键的内部和外部关系:

CSO stakeholders, including clinical study team members

CSO利益相关者,包括临床研究团队成员

KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTS知识、技能、正规教育和经验要求:

A. Formal Education And Experience Required正规教育和经验要求:

Bachelor or Master degree  

Experience in pharmaceutical industry, clinical related discipline/familiarity

Good command of English communication skills(verbal and written if English is second language)

General understanding of R&D and previous exposure to GCPs/ICH desired.

学士或硕士学位

制药行业经验,临床相关学科/熟悉

良好的英语沟通能力(如果英语为第二语言,要求口语和写作能力

了解R&D

 

B. Knowledge and skills 知识和技能:

High attention to detail and accuracy

Understands the clinical development process and GCPs

Consistently meets deadlines according to accepted levels of quality,

Ability to follow guidelines precisely and to follow through on all tasks

Provides high quality results

Familiarity with Windows-based computer applications (e.g., MS EXCEL, ACCESS and Powerpoint)

Detail-oriented and good organizational skills important

Ability to work effectively in a team

Effective written and oral communication in English, and interpersonal skills

Knowledge of Sanofi-aventis SOPs

高度关注细节和准确性

了解临床发展过程和GCPs

按照公认的质量水平始终如一地满足期限,

准确地遵循指导方针和完成所有任务的能力

提供高质量的结果

熟悉基于windows的计算机应用程序(如excelAccessPowerPoint

注重细节和良好的组织能力

能够有效地在团队中工作

有效的书面和口头英语沟通能力和人际交往能力

知识赛诺菲-安万特公司的SOP

 

JOB DESCRIPTION  5

Medical Reviewer

Job Title: Medical Reviewer 医学审稿

DepartmentClinical临床

Numbers: 2

Location: Chengdu成都高新区

Salary8000-10000(本科研究生),12000(博士)年终奖20%,全医疗保险,五险一金

 

A. Knowledge And Skills知识和技能:

A. JOB SUMMARY工作描述:

 Briefly summarize the primary purpose or function of the job (why does itexist?)

知识、技能、正规教育和经验要求(最低)

The MR supports the Clinical Study Directors (CSDs) in the medical supervision and scientific

支持临床研究主任(CSD)进行医学监督和科学研究

 

management of all clinical trials handled by the Clinical & Sciences Operation Platform (CSO) ofSanofi R&D.The primary purpose of the MR position is to operationally support study CSDs on safety andefficacy data medical review and validation.

管理由赛诺菲研发的临床和科学操作平台(CSO)处理的所有临床试验。主要目的是在操作上支持研究CSD在安全性和有效性数据医学审查和验证。

 

Scope of activities include all clinical trials or projects related to clinical development (excludingPhase I in healthy subjects, POC managed by CEP and non Sanofi sponsored studies).

活动范围包括所有与临床发展有关的临床试验或项目(不包括第一阶段在健康受试者,POC管理的CEP和非赛诺菲赞助的研究)

 

Under the guidance of Medical Review Team Leader and following CSDs instructions:he/shecollaborates with the Clinical Scientists, CTOMs, Coding specialists/Dictionary Managers,Biostatisticians, TIM (BICC), Pharmacovigilance representatives, Medical Writers on deliveringhigh quality medical data in prespecified timframe, as needed.

在需求情况下,在医学评审小组负责人的指导和CSDs的指导下,与临床研究员,CTOMs,编码专家/字典经理,生物统计学家,TIMBICC),药物警戒代表,医学撰写人在预先规定的时间范围内提供高质量的医学数据,

 

He/she supports the CSDs to ensure appropriate documentation and consistency of the data and  nvestigations of safety cases with the Clinical Trial Team or Pharmacovigilance.

/她支持CSD确保临床试验团队或药物警戒的相关文件和数据的一致性以及对安全案例的调查。

 

Medical and Scientific expertise. 医学和科学专门知识

High level of autonomy, motivation, good communication skills as well as team player

高度的自主性,积极性,良好的沟通能力和团队合作精神。

 

Autonomous, proactive, able to drive an activity until final deliverable

自主,积极主动,能够推动活动直到最后交付。

 

Self-motivated & results oriented with attention to detail

自我激励,注重细节,注重结果。

 

Quality focused and well organized

注重质量,组织良好

 

B. Formal Education And Experience Required正规教育和经验要求:

Medical educational background with M.D. or Master or PhD degree

医学博士或硕士或博士学历

Physician with clinical practice experience in hospitals at least 1 year

在医院有1年以上临床实践经验的医师

Prior to consider previous medical validation/review experience in Clinical Research and/orClinical DrugDevelopment (e.g., at least 1 year within pharma industry or CRO)

以前考虑在临床研究和/或以前的医疗验证/回顾经验Clinical DrugDevelopment(例如,至少1年在制药行业或CRO

Knowledge in ICH, GCP

ICHGCP经验

Fluent in English (spoken and written)

流利的英语(口语和书面)

 

C. Knowledge And Skills Desirable But Not Essential 知识和技能可取但不是必需的:

Technical技术 : knowledge in reporting tools and technics 报告工具和工艺知识

 

MAJOR DUTIES & RESPONSIBILITIES: Briefly describe the major duties and

responsibilities for which the job is held accountable (what the job does, why is it

done/impact)

主要职责:简要描述主要职责及负责任的完成职责(工作是什么,为什么?完成/影响)

1.

Conduct medical validation/review tasks directly

直接进行医疗验证/检查任务

Execute related tasks taking directions from Team Leader and following CSDs instructions through

medical validation/review plan, other type of quality documents, or through direct communication

Ensure that activities are conducted in adherence with quality standard, and that deliverables are met, inaccordance with CSDs needs, and with respect to study timelines

执行相关的任务,以向团队领导和机构通过以下指令医疗验证/审查计划,其他类型的质量文件,或通过直接沟通确保活动符合质量标准,并满足交付的要求。

2.

Conduct medical validation/review according to compound safety profile, study population characteristics, study design and efficacy criteria

根据复合安全档案进行医疗验证/检查,研究人群特征,研究设计和疗效标准

3.

Review/comment/provide input at Medical Validation KOM, Medical review plan KOM. Participate in updateof MVP/MRP base on new information during course of study conduct

评论/评论/提供医学验证控制输入,医疗评审计划控制。参与更新基于新信息在学习过程中的应用

4.

Set up /schedule medical review resolution meetings with CSDs (GSOs ad hoc), Schedule CIOMS/PPreview reconciliation meetings with CSDs (CTOMs or CMEs ad hoc)

建立/安排医疗审查决议会议与CSDs(政府资助机构Ad Hoc),计划组织/聚丙烯CSDs审查和解会议(CTOMs和日冕物质抛射的Ad Hoc

5.

Working with Team Leader, taking into account CSDs’ perspective on the task allocated. Define prioritiesfor the allocated tasks

与团队领导的工作,考虑到机构的角度对任务分配。确定优先次序用于分配的任务

6.

Interact with Team Leader regularly on tasks advancement and completion, difficulties encountered, andpotential delays

定期与团队领导沟通任务的完成和完成,遇到的困难,以及潜在的延误

7.

Define timelines for completion of each task, in coordination with team Leader and CSDs

定义每个任务的完成时间,协调小组组长CSDs

8.

Proactively communicate with other functions (eg TO, GPE, CSU, CDOC, TIM (BICC) and so on) to

resolve safety data issues timely and effectively

主动与其他交流功能(如,GPECSU,有色可溶性物质,提姆(BICC)等)来及时有效地解决安全数据问题

 

A. Major Challenges/Problems: List challenges or problems commonly encountered in this job,how they are solved, and with whom they would typically be solved.Meet customer expectation in term of deliverablesDeliver on time, according to study timelines, and with high quality Active collaboration with CSDs for developing trust and effectiveness Appropriate and Strategic approach for PP medical review, CIOMS/PP reconciliation, ie., clearunderstanding of definition of critical data accompanied with clear understanding that non-criticaldata is “out of medical review scope of work”Productivity development

主要的挑战和问题:列表的挑战和问题在工作中经常遇到的,他们是如何解决的,而且他们通常会解决。满足在deliverablesdeliver时间期限的顾客期望,据研究时间表,并与PP的医疗审查发展信任和有效性和高质量的战略方针,CSDs积极合作,根据PP和解,即认清关键数据有清醒的认识,非数据是“不工作”的生产力发展的医疗审查范围的界定

 

B. Key Internal and External Relationships. Describe the most significant contacts outside theregular work unit. Include frequency and purpose.Medical Validation Team leader, CSDs within OMD&CD, Clinical Scientists, Coding Specialists, CSUs,Medical Advisors, GPE: Case Medical Evaluators, PV scientists, Global Safety Officers, CTOMs,Medical writers

关键的内部和外部关系。描述了最重要的联系人外正常工作单位。包括频率和目的。医疗团队的领导者,CSDsOMDCD,临床研究员,编码专家、心理、医学顾问、GPE:医学评估,光伏研究员,全球安全的官员,CTOMs

 

VI – ACCOUNTABILITY (FORMERLY JOB SCOPE)

A. Decision Making Authority: Identify the types of decisions made by this job as well as thosethat must be referred to a superior (i.e., authority to implement plans, personnel decisions,changes to policy, etc.)

决策权:识别以及那些工作由决策的类型必须提交上级(即权力实施计划、人事决策、政策的改变,等等)

Influences

- Best approach for study monitoring/conduct

- Safety data quality of the studies

影响

-研究/监测的最佳方法

-研究的安全数据质量

 

 

JOB DESCRIPTION  6

Medical Coding Specialist

Job Title: Medical Coding Specialist医学编码研究员

Numbers: 1

Location: Chengdu成都高新区

Salary8000-10000(本科研究生),12000(博士)年终奖20%,全医疗保险,五险一金

 

Job Description Form工作描述表

Coding Specialist Head of Clinical Scientists, Medical Coding &Review

编码专家,临床研究员,医学编码和评论

 

Knowledge And Skills 知识和技能:

A. JOB SUMMARY: Briefly summarize the primary purpose or function of the job (why does itexist?)

工作概述:简要总结工作的主要目的或功能(为什么itexist?)

 

The coding specialist ensures coding of medical events and medications using regulated dictionaries and in compliance with international rules.

编码专家确保使用规范的词典和国际规则对医疗事件和药物进行编码。

 

He/she is fully aware of the dictionaries structure and updates and their related impacts on terms classification.

员工需完全了解字典结构和更新及其对术语分类的相关影响。

 

He/she validates the coding, with input from clinical study director (CSD), taking into consideration medical aspects such as the compound mechanism of action, the study population or any specificity as defined in the study protocol.

通过临床研究主任(CSD)的输入来验证编码,同时考虑到医学方面,如复合行动机制、研究人群或研究协议中规定的任何特殊性

 

He/she assists the clinical study director in understanding and retrieving the coded events.

协助临床研究主任理解和检索编码事件

 

He/she can provide provide input on CRF design.

可以提供CRF设计的输入。

 

He/she, in collaboration with case medical evaluator (CME), ensures that SAE are reported and coded in a consistent way within both clinical and GPE database.

与案例医学评估员(CME)合作,确保SAE在临床和GPE数据库中以一致的方式报告和编码。

 

He/she can detect and alert the CSD for unexpected medical events.

/她可以检测和提醒CSD突发医疗事件。

 

To better serve some customers, the coding specialist can be dedicated to one therapeuticarea (Oncology, Diabetes, …)

为了更好地服务于一些客户,编码专家可以致力于一个治疗领域(肿瘤学,糖尿病...

 

- Ability to communicate and work within a global team

- Ability to understand and process several levels of information for multiple projects

- Knowledge in ICH, GCP

- Good command of the English language

-能够胜任在全球团队工作

-能够理解和处理多个项目的多个级别的信息

-ICHGCP相关知识

-熟练掌握英语

 

B. Formal Education And Experience Required:

- Physician, Pharmacist, Nurse or paramedical professional with minimally a Bachelor Sciences.

- Previous experience in coding and coding dictionaries, preferably MedDRA, WHODD

- Previous experience in Clinical Research and/or Drug Development

教育和经验要求:

-医师、药师、护士或护理专业本科科学与微创。

-以前的编码和编码字典,经验,MedDRAwhodd

-有临床研究和/或药物开发经验

 

C. Knowledge And Skills Desirable But Not Essential:

- Working knowledge of various coding systems and related third party tools, familiar with auto-encoding algorithms

- Familiar with database structure, and able to query them through SQL for example

知识和技能可取但不是必需的:

-熟悉各种编码系统和相关的第三方工具,熟悉自动编码算法

-熟悉数据库结构,并能够通过SQL查询它们,例如

 

MAJOR DUTIES & RESPONSIBILITIES: Briefly describe the major duties and

responsibilities for which the job is held accountable (what the job does, why is it

done/impact)

简要描述主要职责及负责任的完成工作(工作是什么,为什么?完成/影响)

 

1.

Coding referent for study(ies) he/she is allocated to, primary contact for coding concerns.

Accountable for the coding of events and drugs (in compliance with ICH guidelines for events), ensure ongoing coding of studies including query generation for ambiguous medical terms.

Ensure coding consistency review.

编码的研究对象,他/她被分配,主要接触编码的关注。

负责事件和药物的编码(符合ICH事件指南),确保正在进行的研究编码,包括模棱两可的医学术语的查询生成。

确保代码一致性检查

2.

Medical validation of coding with CSD.

Ensure coding reconciliation of SAE with GPE.

Help in appropriate documentation and investigations of safety cases in collaboration with GPE, identify reporting issues and provide solutions.

CSD编码的医学验证。

确保编码SAEGPE和解。

有助于安全的情况下,适当的文件和调查合作与GPE,鉴定报告问题并提供解决方案。

3.

Provide input and help in CRF design (pre-printed events, medication categories, etc…).

Review study documentation (DRSP, DMP, …) for coding related elements.

Propose coding related edit checks to SDM.

CRF设计(预印事件、药物分类等)中提供输入和帮助。

回顾研究文件(DRSPDMP,…)编码相关的元素。

SDM提出与编码相关的编辑检查。

4.

 Attendance to study team meetings and explanation or training to study team members when appropriate.

参加学习小组会议,并在适当时学习或解释团队成员

5.

Assist CSD in providing answers to questions (from Health Authorities, etc…) targeting coded data.

协助CSD提供针对编码数据的问题(来自卫生部门等)的答案

6.

Provide help to the dictionary manager for dictionary and synonyms management.

向字典管理器提供字典和同义词管理的帮助

 

A. Major Challenges/Problems: List challenges or problems commonly encountered in this job,how they are solved, and with whom they would typically be solved.

Maintaining a high level quality of the coding done while meeting timelines. Solved by anticipating activities, organizing his work, and keeping a team spirit.Customer satisfaction.

主要的挑战/问题:

列出在这项工作中经常遇到的挑战或问题,以及如何解决这些问题,以及通常与谁一起解决这些问题。

在满足时间表的同时保持高质量的编码。通过预期活动解决,组织工作,保持团队精神。

 

B. Key Internal and External Relationships. Describe the most significant contacts outside the regular work unit. Include frequency and purpose.

Strong collaboration with the Clinical Study/project Team of the CSO Platform..

Strong interaction with the CSD and CME

关键的内部和外部关系。

描述正规工作单位以外最重要的联系人。包括频率和用途。

CSO平台的临床研究/项目团队紧密合作。

CSDCME密切互动

 

VI – ACCOUNTABILITY (FORMERLY JOB SCOPE)

A. Decision Making Authority: Identify the types of decisions made by this job as well as those that must be referred to a superior (i.e., authority to implement plans, personnel decisions, changes to policy, etc.)

Individual decisions: Coding decisions, work organization.

Decisions that must be referred to a superior or responsible outside the work unit: Changes to coding policy.

Influences: Data collection, Data review on particular aspects according to coding findings or results.

决策权:确定由这项工作做出的决定的类型,以及那些必须提交给上级的决定(例如,执行计划的权力、人事决定、政策的改变等)。

个人决策:编码决策,工作组织。

必须向工作单位以外的上级或负责人作出的决定:编码政策的变更。

影响:数据收集,根据编码结果或结果对特定方面进行数据审查。

 

 






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