湖州招聘

The Senior Clinical Database Analyst - II is the database expert and responsible for developing and implementing database elements (structure, data entry screens, edit checks) and he/she is also responsible for setup of peripheral tools of clinical database collection system. He/she ensures that any study databases are set up and maintained according to defined timelines. He/she manages the study databases in compliance with the worldwide clinical standards to support a flawless conduct of clinical trials. He/She is the expert for Clinical study database, eCRF and standards.

Technical knowledges

Advanced expertise in Clinical Data Management Systems (e.g., Clintrial, Oracle Clinical, Medidata Rave) and in the use of Data Management applications and database/file structures

Advanced expertise in database administration, design/programming, query language and metadata validation

Expertise of industry standards and practices (e.g. CDISC/CDASH/SDTM)

Expertise of Microsoft Project to develop Gantt.

Problem solving & Decision making

Anticipate complex problems and proactively works to minimize the impact. Delivers on commitments with high quality results.

Ability to analyze issues (i.e. context, impact risk)

Ability to make decisions when needed and take responsibility (accept accountability for results, even if the outcomes are difficult or sensitive)

Oversight & Coordination

Ability to performing quality controls and ensuring deliverable for the projects of junior team members.

Ability to perform quality control for the outsourced activities.

Strong organizational skills and ability to handle multiple tasks, paying attention to details and defining priorities.

Act for change

Be flexible to change, managing internal and external challenges & opportunities

Readily adapt to new environment, jobs, technologies and processes (e.g. new CDMS, tools, process of UNIFY)

People development

Ability to coach/supervise new CDA in the areas of standards, database administration, design and programming

KEY ACCOUNTABILITIES:

MAJOR DUTIES & RESPONSIBILITIES

END RESULTS EXPECTED

(why is it done/impact)

1.

- Responsible for developing/update study setup Gantt Chart to comply with study timeline, and followup the data management related tasks implementation per Gantt.

- Responsible for designing study database/eCRF per protocol, and implement dynamism and edit check programming per data collection and cleaning needs in current clinical data management systems (Oracle Clinical/ Medidata Rave).

-Proactively attend eCRF review meeting, present and discuss with study team members to ensure the high quality CRF/database.

-Host regular meeting with outsourced DBDs to ensure the corresponding deliverable.

-- Responsible for the CDMS peripheral tools setup for example SAGA, EDL.

- Responsible for clinical database post production maintenance including database change impact and assessment analysis and database migration.

-Responsible for clinical database lock.

- All standards and studies are implemented according to Sanofi SOPs, processes and standards to ensure high quality of data management

2

Request new database models or updates to Clinical Information Governance team (CIG).

Actively attend CIG CT/CRF review meeting and provide the appropriated input.

High quality database complying with standards.

3

Responsible for configuring peripheral tools for clinical data management system including SAGA, EDL, eLoader and RELAX per the needs.

The peripheral tools should work well and ensure the integration with the CDMS.

4.

Expert contact for Study Data Managers (SDMs) or CTOM (Clinical Trial Operation Manager) concerning database support activities; proposes solutions for data management issues that arise during study conduct.

All databases are compliant with the level of quality required by ICH/GCP in order to deliver reliable and accurate data computerized for statistical analysis

5.

- Expert contact for new technical solutions (associated with clinical data management systems) implementation and processes in interaction with the appropriate working groups.

- User testing of relevant software patches/upgrades

- New solutions are implemented

- New softwares are implemented

6.

Interacts closely as an expert in database design with CRF Designer for paper CRF study

All CRFs include database constraints. Same elements are included in the CRF and as well in the database modules.

7.

Supprot TL/GL to provide the experise regarding database metrics/KPIs , process excellence and operational efficiency especially how to optimize database.

High efficiency around database implementation.

8.

Serve as an expert for coaching new DBD in the areas of standards, database design and programming.

Smooth integration of new comers in the Database design group

9.

Within database design, standards group, continually evaluates processes and applications for improvements, as well contributes to improvements within CDM generally.

Participates in the implementation of department initiatives (e.g. new tools, new standards, process improvements).

Participates in working groups to develop and implement new applications and procedures.

Maintains knowledge of current regulations and technologies related to the data management function. Deputizes for the Standard Implementation Head, Study Implementation Manager,  when appropriate.

Best practices applied to all aspects of database design activities.

JOB-HOLDER ENTRY REQUIREMENTS:

Education:

Bachelor degree, preferably in a life science or mathematics-related area (e.g., computer science or similar technical field).

Experience:

At least 5-6 years experience in clinical database design and maintenance are required and he/she can lead database design for complex phase II/III trails independently. In addition, clinical trial experience, clinical data management experience and pharmaceutical industry experience are preferred.

赛诺菲集团
赛诺菲集团是一家全球领先的多元化医药健康企业，专注于患者需求，传播健康。
 全球100,000余名员工，业务遍及100个国家
 新兴市场实力均衡，表现强劲，位列***
 多元领域，覆盖处方药、健康药业产品、疫苗和动物保健品
 疫苗领域的领导者
 领先动物保健市场
 2011年集团净销售额达334亿欧元

赛诺菲在中国
赛诺菲是首批在中国开设办事处的跨国制药集团，也是国内增长最快的医药健康企业之一。目前，赛诺菲在中国200多个城市拥有6000余名员工。
   
传承悠久历史、持续开拓进取
赛诺菲一直以来秉承对中国的承诺。1982年，赛诺菲成为首批在中国开设办事处的跨国制药企业之一。今天，赛诺菲已跻身中国医药健康市场的领军企业。赛诺菲的中国总部位于上海，并在北京、天津、沈阳、济南、上海、杭州、南京、武汉、成都、广州和乌鲁木齐共设11家区域办公室。

独特的医药健康产品系列、满足中国公共卫生需求
从预防到治疗，赛诺菲全方位满足中国的公共健康需求。集团的疫苗事业部赛诺菲巴斯德是中国领先的疫苗企业。赛诺菲在心血管/血栓、糖尿病、肿瘤、内科和中枢神经系统等关键的治疗领域拥有领先产品。2010年，杭州赛诺菲民生健康药业有限公司的成立标志着赛诺菲进入中国的非处方药市场。2011年2月，赛诺菲完成了对BMP太阳石的收购。

大幅投资工业建设、满足中国市场需求
赛诺菲目前在中国拥有六家生产基地，包括北京制药工厂、杭州制药工厂、杭州赛诺菲民生健康药业工厂、南昌梅里亚动物保健工厂、深圳赛诺菲巴斯德疫苗工厂、以及唐山健康药业工厂。

完善的研发架构、双赢的研发合作模式
在中国，赛诺菲具有从药物靶点发现到后期临床研究的整体研发实力。集团在上海设有中国研发中心和亚太研发中心，并在北京和成都分别设有研发机构。自2008年以来，赛诺菲与中国权威科研机构开展了10多项战略合作，在癌症、干细胞、糖尿病和老年疾病等前沿研究领域探索创新药物

依托于强劲的研发能力和多领域领先水平的广泛的医药产品资源，公司在中国的市场份额不断攀升，公司规模不断扩大，飞速发展的业务给了我们与更多优秀人才合作的机会。

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