临床数据管理经理
煌途(北京)科技有限公司
- 公司规模:150-500人
- 公司性质:合资
- 公司行业:制药/生物工程
职位信息
- 发布日期:2017-04-20
- 工作地点:北京
- 招聘人数:1人
- 工作经验:2年经验
- 学历要求:本科
- 职位月薪:2-2.5万/月
- 职位类别:临床数据分析员
职位描述
职位描述:
Data Management
?Renew and/or revise SOPs as necessary to ensure the efficient procedures.
?Manage project status.
?Manage system implementation project.
?Utilize computerized tools to increase efficiency and precision.
?Construct database, maintain access control, maintain database to ensure data completeness.
?Develop data entry instruction and data validation plan/checklist.
?Develop edit check and logic check specifications.
?Design Case Report Forms (CRFs).
?Process DCFs for query generation, schedule and tracking management.
?Capture all changes to clinical data.
?Ensure trial documentations comply with HT-Med guidelines.
Statistical Analysis
?Renew and/or revise SOPs to ensure the efficient procedures.
?Manage project status.
?Review literature for protocol development on analysis methodologies, sample size estimation, randomization/blinding schema.
?Develop and ensure the validity of statistical analysis plan, statistical programming.
?Develop statistical programs for data listing, summary tables, and trial figures.
?Participate in clinical study reports and ensure the quality of reports.
?Utilize computerized tools to increase efficiency and precision.
?Ensure trial documentations comply with HT-Med guidelines.
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Data Management
?Renew and/or revise SOPs as necessary to ensure the efficient procedures.
?Manage project status.
?Manage system implementation project.
?Utilize computerized tools to increase efficiency and precision.
?Construct database, maintain access control, maintain database to ensure data completeness.
?Develop data entry instruction and data validation plan/checklist.
?Develop edit check and logic check specifications.
?Design Case Report Forms (CRFs).
?Process DCFs for query generation, schedule and tracking management.
?Capture all changes to clinical data.
?Ensure trial documentations comply with HT-Med guidelines.
Statistical Analysis
?Renew and/or revise SOPs to ensure the efficient procedures.
?Manage project status.
?Review literature for protocol development on analysis methodologies, sample size estimation, randomization/blinding schema.
?Develop and ensure the validity of statistical analysis plan, statistical programming.
?Develop statistical programs for data listing, summary tables, and trial figures.
?Participate in clinical study reports and ensure the quality of reports.
?Utilize computerized tools to increase efficiency and precision.
?Ensure trial documentations comply with HT-Med guidelines.
职能类别: 临床数据分析员
关键字: 带薪年假 周末双休 年终双薪 立即上岗
公司介绍
Beijing Health Tech Medical Group (HT-Med) was founded since 2004. We are a comprehensive medical Operation and development organization .Assemble excellent talents of medicine, pharmacy, data management and statistical fields, offering professional services to support biotech and pharmaceutical companies at every stage of product lifecycle .
We provide Medical translation, Data Management, Statistical Analysis, Medical Writing, Regulatory Affairs, Project Evaluation and Management, Independent Audit, Training, CRA/CRC/DM dispatch. Since we established, we were developing new drugs with Chinese Academy of Medical Sciences, Peking University Health Science Center, The General Hospital of the PLA, Military Medical Sciences, etc. Has cooperated with over 90% clinical trial sites (hospital) approved by SFDA.
We developed independently EDC+CTMS by ourselves, obtained 3 patents and 2 brands. Basing on excellent IT capability, we develop Products Data Center for our clients, and created role exchange pattern between CRA and CRC, improved speed&quality of Clinical Study by the model of EDC+CRC, especially in PMS. We have been became the vendor of lots of global company (AZ, GSK, BI, Abbott, Roch, Mundipharma, QPS etc.) and some official Institution (Chinese Academy of Medical Sciences, Peking university, The general hospital of Chinese PLA, Sanming hospital, Zhejiang oncology hospital, Academy of Military Medical Sciences of the Chinese PLA etc.).
We are familiar with China SFDA policy and CDE mentality, possessing mass of expert resource and marketing support. we could cover 90% Chinese certificated clinical research hospital by lots of home-based employee in 18 cities.
公司邮箱:yanmei.wang@ht-med.com
公司网址:http://www.ht-med.com
We provide Medical translation, Data Management, Statistical Analysis, Medical Writing, Regulatory Affairs, Project Evaluation and Management, Independent Audit, Training, CRA/CRC/DM dispatch. Since we established, we were developing new drugs with Chinese Academy of Medical Sciences, Peking University Health Science Center, The General Hospital of the PLA, Military Medical Sciences, etc. Has cooperated with over 90% clinical trial sites (hospital) approved by SFDA.
We developed independently EDC+CTMS by ourselves, obtained 3 patents and 2 brands. Basing on excellent IT capability, we develop Products Data Center for our clients, and created role exchange pattern between CRA and CRC, improved speed&quality of Clinical Study by the model of EDC+CRC, especially in PMS. We have been became the vendor of lots of global company (AZ, GSK, BI, Abbott, Roch, Mundipharma, QPS etc.) and some official Institution (Chinese Academy of Medical Sciences, Peking university, The general hospital of Chinese PLA, Sanming hospital, Zhejiang oncology hospital, Academy of Military Medical Sciences of the Chinese PLA etc.).
We are familiar with China SFDA policy and CDE mentality, possessing mass of expert resource and marketing support. we could cover 90% Chinese certificated clinical research hospital by lots of home-based employee in 18 cities.
公司邮箱:yanmei.wang@ht-med.com
公司网址:http://www.ht-med.com
联系方式
- 公司网站:http://www.ht-med.com1SOPCRA2CRAsPMTMF3PM412CET-6,3GCP4
- Email:yanmei.wang@ht-med.com
- 公司地址:地址:span上海浦东新区张江高科技园区亮景路199号