Clinical Data Analyst I/ II/ Senior 上海

月薪： 7-10万/月

该公司所有职位
  • 无工作经验
  • 招若干人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 补充公积金
  • 员工旅游
  • 专业培训
  • 弹性工作
  • 定期体检

职位描述

职位描述： The role of the Clinical Data Analyst (CDA) is to perform all clinical data cleaning activities onassigned projects, commensurate with experience and/or project role. Key activities include datavalidation, generation and integration of queries, coding of clinical data, reconciliation of safety andelectronic data.The Clinical Data Analyst will assume the Clinical Data Manager responsibilities on studies that startedKey Account abilities- Utilize current study documentation including protocol, Case Report Forms (CRFs), Cleaningguidelines etc.- Conduct in-house data review- Generate and close queries or apply self evident corrections to the data according to the relevantguidelines- Identify and report protocol violations- Manual and Patient Profile review, issue queries- Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groupsof possible issues for their action- Track and integrate queries- Perform clinical coding if appropriate to role within the project team- Ensure all documents coded for submission to central files- Lock site(s) within EDC system - remove user's data modification privileges- Interact with site (via mail) as required- Perform early and final database QC activities- Update all relevant tracking system on an ongoing basis- Inform responsible CDA coordinator of work status regularly- Keep manager informed about work progress and any issues to avoid surprises. Requiresregular interaction / supervision by Manager or assigned mentor- Maintain a working knowledge and ensure compliance with applicable ICH-GCP Guidelines,local regulatory requirements and PAREXEL WSOP and stud specific procedure- Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travelexpense claimsSkills- Good computer skills including but not limited to the knowledge of Clinical Trial/DataManagement Systems, PMED, MS-Office products such as Excel, Word.- Demonstrate a sound awareness of all relevant regulations, including GCP- Ability to successfully work in a (‘virtual’) team e***ironment- Client focused approach to work- If required, knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG)- Solid interpersonal, verbal and written communication skills- Sense of urgency in completing assigned tasks- Meticulous attention to detail- Effective time management in order to meet daily metrics or team objectives- Shows commitment to and performs consistently high quality workEducation- Bachelor’s degree and / or other medical qualification or relevant DM experience- Competent in written and oral English 职能类别： 临床数据分析员 生物工程/生物制药

联系方式

上海市浦东新区银城中路488号太平金融大厦20层

公司信息

精鼎医药研究开发(上海)有限公司(PAREXEL International)，成立于1982年，是一家致力于药物临床试验研究的CRO (Contract Research Organization)集团公司。总部位于美国，分支机构遍布欧、美、亚、大洋四大洲，且于亚洲13个国家和地区设立了分支机构，致力深耕于当地。精鼎医药由一群具有丰富跨国性临床试验研发经验及专业知识的精英所组成，服务团队集合各种不同专业领域的人才。我们重视与客户的承诺，更重视人才的培育和养成，我们提供完整的教育训练、职涯规划、优于市场的薪资福利、良好工作环境，期许同仁与公司一同成长，迈向未来。 愿景（Vision）： 创造一个在亚太地区具有国际竞争力的最精良CRO团队。 发展使命（Mission）： 1．争取国际大药厂委托，执行符合国际水准的跨国性临床试验。 2．协助亚太生技及制药产业建立新药开发模式，以提升产品研发能力，幷促使产品国际化。 3．以提升临床试验品质为宗旨，拓展全球市场为目标，整合计算机及通讯科技，在国际上提供客户兼具成本效益及效率的临床试验数据处理中心。 4．建立一个以亚洲人种高发生率疾病的基因数据库，以提供国际性新药研发机构所须之基因信息，协助其缩短药物开发时程，幷提高研发成功率。 公司福利和人才培养计划： 保险类： 1. 社会保险(依照国家规定)及住房公积金； 2. 团体保险（包括寿险、意外暨医疗保险）； 3. 补充医疗保险； 制度类： 1. 学习发展计划 (Learning & Development): 针对个别员工之专业及兴趣，设计符合其个人之生涯规划； 2. 完整的教育训练：每年公司均针对所有员工，提供完整之教育训练； 3. 顺畅的升迁管道及可转调其它部门；如有职缺，亦可申请调至海外各子公司； 请 / 休假制度： 1. 服务第一年即享有14天年假, 后续年休假天数则依据服务年资及公司制度而定； 2. 一年可享12天不扣薪病假； 3. 员工旅游, 年度体检； 精鼎医药将以培养国际性的人才为目标，欢迎具有国际观之人才加入。 应聘方法： 1.    在线投递； 2.    请登录我们的公司网站直接投您的简历（https://jobs.parexel.com/search-jobs） 我们在收到您的简历之后，会尽快与您联系。 谢谢！

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