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无工作经验 -
本科 -
招若干人 -
11-09 发布
- 五险一金
- 补充医疗保险
- 定期体检
职位描述
职位描述： 职位概述：按照要求提供数据管理方面的专业知识，参与所分配项目中与数据管理相关的服务。主要岗位职责：协调临床数据管理过程，保证临床研究数据的及时性、真实性、准确性和完整性；进行病例报告表数据的日常检阅以及质疑表的处理；实施数据录入以及数据的双份录入和一致性比对；按照数据核查计划核查数据，对可疑数据发布数据质疑表，解决数据质疑，并更新数据库；为临床研究方案的设计提供数据管理支持和审阅；参与数据管理计划、核查计划等相关文档的撰写和审阅。Position Purpose?Responsible for ensuring the completeness, quality and integrity of the subject data in the clinical trial database.?Ensure the consistent use and application of applicable data standards. The ultimate objective is to ensure data quality and consistency across programs and repositories.?Responsible for data management activities within a clinical trial, according to regulations, applicable Standard Operating Procedures (SOPs) and Processes.?Works with the global study team to meet the study objectives.Primary Responsibilities General?Ensure that all data components are conducted in compliance with GCP, relevant SOPs, and regulatory requirements.?Ensures Conformance to Pfizer Data Standards.?Actively participates in monthly project review meetings.?May participate in Therapeutic Area (TA) specific process improvement initiatives.Hands-on data management responsibilities (Data Manager):?Create and implement the Data Management Plans (DMP) to ensure data completeness and accuracy.?Set-up and test data review listings to verify the quality and completeness of data as specified in DMP.?Ensure timely set-up of clinical data acquisition and management tools and data validation.?Maintain study tracking to ensure timely CRF retrieval, data entry and data cleaning activities.?Perform data cleaning activities including discrepancy management (review of errors from electronic checks) and review of data listings to verify quality and completeness of data.?Ensure integrity of clinical data and update database by issuing and resolving DCFs as necessary.?Reconcile the patient database with the Serious Adverse Event database.?Document all efforts of data management and file all responsible documents.Technical Skill Requirements?Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP?Demonstrated knowledge of data management processes and principles in area of responsibility.?Works independently, receives instruction primarily on unusual situations?Ability to organize tasks, time and priorities; ability to multi-task?Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally?Ability to work in ambiguous situations within teams to identify and articulate complex problems?Demonstrated knowledge of clinical development and regulatory submission processes and requirements.?Knowledge/proficiency/understanding of technologies to support data acquisition, computerization and data validation, computer systems life cycle technology?Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.Qualifications?Bachelor degree or equivalent in a natural/medical science, data management or related discipline.Preferred Additional Experience?Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design?Previous experience within a data management role, understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, DMPs and data cleaning activities?Knowledge of clinical trial database and its applications?Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.) 职能类别： 临床数据分析员
联系方式
湖北省武汉市东湖高新区高新大道666号光谷生物城
公司信息
上海康德弘翼医学临床研究公司是药名康德全资子公司，药明康德新药开发有限公司于2000年12月成立，是全球领先的制药、生物技术以及医疗器械研发开放式能力和技术平台公司，在中美两国均有运营实体。作为一家以研究为首任，以客户为中心的公司，药明康德向全球制药公司、生物技术公司以及医疗器械公司提供一系列全方位的实验室研发、研究生产服务，服务范围贯穿从药物发现到推向市场的全过程。药明康德的服务旨在通过高性价比、高效率的研发服务帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。 十多年来，药明康德成功打造了全方位一体化的研发服务技术平台。创建之初，药明康德凭借其在发现化学合成领域的雄厚实力实现了全面发展。近几年来，我们又新增了一系列一体化服务，包括分析服务、生物分析服务、工艺研究、工艺研发服务、API生产服务、药物代谢及其动力学服务、研发生物学、药理学、制剂、毒理学、基因组服务、生物制剂生产服务、抗体及生物诊断试剂的生产和销售服务以及临床研发和产品注册服务等。 从 2000 年 12 月创立至今，药明康德的员工数从4 人增长至 10000 人，实验室由当初仅有的一间增长到近46 万平方米已有及在建研发基地和生产厂房。与此同时，药明康德还在不断增强服务能力，拓宽服务领域，以更好地服务公司持续增长的全球业务需求。作为一家全球领先的医药研发服务公司，药明康德将继续致力于在中美两国为全球客户提供高质量的医药研发服务，帮助研发出更多造福患者的新药及产品。 回望昔年，药明康德已经走过了15年的历程。15年走来，我们见证了新药研发的飞速发展，见证了众多科学家在新药研发中实现梦想，见证了全球2000多家企业攻克越来越多的疾病，见证了越来越多患者脸上渐渐浮现的微笑，同时也见证了药明康德人从无到有将药明康德建成一个无论在亚洲还是在全球医药行业里独一无二的研发生产技术能力平台性公司。 未来我们的发展方向：一是继续将一体化、开放式的研发生产技术能力平台做大做强，继续延揽建立全球最尖端的医药研发技术，包括基因诊断、细胞基因治疗、基因编辑以及一些高端创新药物的研发、生产等。二是更加致力服务中国的大健康产业，通过我们的平台连接“人与健康”，让国际尖端医药技术能为广大国内患者和老百姓所用。 面对2016年，回归成为私营公司的药明康德将更加专注，专注于公司创业之初变革新药研发的梦想。不忘初心，方得始终。药明康德人将继续坚守我们的初心与梦想，在新的征程中，实实在在地推动人类健康。欢迎加入药明康德大家庭，与我们携手一起开启未来，创造未来，享受未来！ 如需了解更多，欢迎访问公司网站 http://www.wuxiapptec.com.cn
