Senior Clinical Data Manager招聘_默沙东中国最新招聘信息-猎才医药网

职位描述

JOB DESCRIPTIONSenior Clinical Data Manager – SCDMDivision: MRLArea/ Department:GDMS/GDOReports to (Title):Assoc. Manager, Manager, Senior Manager, Associate Director or DirectorIncumbent:Position OverviewUnder the direction of the applicable management, the Senior Clinical Data Manager (SCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with MSD Standard Operating Procedures (SOPs) and ICH-GCP guidelines.Primary ActivitiesPrimary activities include, but are not limited to:？All responsibilities of a Clinical Data Manager.？Assume data management responsibilities for larger, more complex or higher priority protocols.？May coordinate general ad-hoc Sponsor Data Entry (SDE) process for the protocol, discuss timelines, and provide data entry status to the Clinical Development Scientist (CDS).？Provide protocol specific training of SDE Process to CDM.？Triage, research, discuss and resolve the reports outputs provided by Clinical Development Scientist (CDS) and Statisticians at a protocol level during in-life and database lock stages supported by the LCDM.？Supports the LCDM in the preparation, creation and review of data management tool specifications and tools？Participates in User Acceptance Testing (UAT) of the Clinical Database Repository under the direction of the LCDM.？Coordinates communications, global status tracking and issue resolution at study level with Lead CDM (LCDM).？Responsible for the communication with Clinical Trial Operations team regarding site level issues on protocol a basis on behalf of the LCDM.？Monitor protocol level cycle time performance (metrics) and follow up on specific countries/sites metrics issues and deliver status and resolution updates to LCDM.？Responsible for study level status assessment, reporting and communication with LCDM.？Complete trial level archiving activities under the direction of the LCDM including, but not limited to, filing of essential documentation.？Coordinate and mentor CDMs and other SCDMs who work in his/ her protocol to ensure their compliance with SOPs, data management plans and data review plans.？Be assigned to special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as providing inputs to create or update SOPs, supporting documents and training materials as needed.？May be required to support DMC Process Owner (PO) Models in the local DMC and/or in the Global PO networks.？Participate in cross functional technical or process improvement projects.Manual Encoding Lead？Perform all responsibilities of a Manual Encoder under the Clinical Data Manager.？Ensure encoding accuracy and consistency across all protocols within a project.？Works closely with DMC manual encoders and Data Management Trial Manager (DMTM) to ensure all encoding tasks are completed prior to interim analysis, frozen files/ database locks.？Serves as Subject Matter Expert (SME) for encoding documents and processes.？Responsible to review specified therapeutic area encoding as requested.？Coordinates with LCDM to create and review encoding specifications documents and performs User Acceptance Testing (UAT) of coding application (s).？Responsible for encoding external partner data as applicable and consultant for Contract Research Organization (CRO) partners.？Runs encoding check reports in accordance with data review plans to identify encoding issues.？Raises questions with investigational site staff or DMC manual encoders and reviews responses and corresponding data corrections to confirm resolution.？Responsible for study level encoding status reporting and assessment, and communication with DMC Clinical Trial (CT) management during in-life data management activities and preparation for database lock.RequirementsEducation:1.At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.Knowledge and Skills:1.Two years’ experience in clinical data management in pharmaceutical or health care clinical research environment is preferable.2.Self-motivated, excellent in work planning and time management.3.Fluent oral and written English skills.4.Good basic awareness of the clinical development process.5.Good basic awareness of clinical practice and grasp of medical terminology.6.Good sense and awareness of regulations and policies.7.Able to work under pressure and in a changing environment with flexibility.8.Good communication skills with the ability to communicate with both technical and business areas.9.Proven leadership skills, specifically the ability to coordinate the work of others and influence management on decision making. 职能类别：生物工程/生物制药

公司信息

今天的默沙东正致力于为全世界带来健康的福音。我们为全球140多个国家提供药物、疫苗、生物制剂、健康消费品和动物保健产品，并与客户一起提供创新的健康解决方案。同时，我们还致力于通过各种意义深远的项目向需要帮助的人们捐赠和提供产品，从而扩展人们进入医疗卫生的途径。默沙东，健康是福。默沙东中国的总部设在上海，目前中国大陆地区共有10个分公司和3座工厂，分别在上海，杭州和南京。员工总人数超过5100人。目前，我们在中国提供涵盖心血管、抗感染、***健康、女性健康、骨科、疼痛、皮肤、呼吸、专科药品、辅助生殖、疫苗等领域的46种人用药品。默沙东在中国建有三座工厂，拥有技术水平领先全球的生产设施，一流的环境标、优秀的生产工人以及高水平的管理能力，符合中国药品生产质量管理规范（gmp标准）。我们还向中国市场提供46种动物健康产品，用以预防、治疗和控制家禽家畜以及宠物的疾病。 “我们应当永远铭记，药物是为人类而生产，不是为追求利润而制造的。只要我们坚守这一信念，利润必将随之而来。仅仅发明了一种新药，并非已经大功告成，我们还要探索有效途径，使默沙东的***科研成果，能够造福于全人类。” 乔治默克一九五零年十二月一日我们的事业是救治人类生命、提高生活质量，同时改善动物健康我们坚持最高的道德与诚信标准我们致力于不断提高科学研究水平，以改善人类与动物健康、提高生活质量为己任我们希望的利润，全部来源于满足客户需求，并用于造福社会我们相信公司的成功取决于员工的诚信、知识、想象力、技能、多元化以及团队精神员工是默沙东最宝贵的财富之一。我们坚信，企业的成功归功于每一位员工的诚信、学识、敬业度和责任感。在中国，默沙东注重通过推行完备的人才管理体系，不断提升员工积极性和工作绩效，使他们能够充分发挥才能，并享受工作带来的成就感。广纳良才 —— 寻找、吸引拥有丰富技能和正确职业态度的***人才激情 —— 创建独到的企业文化，让每一位员工充满激情，并且乐于分享企业的价值观和目标发展 —— 创建一种持续学习的环境，让每位员工做到更好激励 —— 对员工做出的贡献进行奖励

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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