南京招聘

职责表述：
·协助部门经理制定部门工作规划
·协助部门经理制定本部门的工作规划
·根据具体工作，制定岗位工作的年度计划、月度计划
·具体负责并参与临床试验项目的数据工作
·负责项目的整体进度跟踪管理工作，解决数据管理过程中出现的问题
·负责对项目的方案、病例表进行研究
·协调组织项目启动会议，提出数据管理的重点、难点，根据项目组意见制定解决方案
·负责项目组的协调和沟通
·负责与客户良好的沟通，如时间进度有变化及时调整项目进度，与客户达成数据处理的协议
·负责协调改进数据管理流程，提高数据管理技术和能力
·负责相关SOP的建立、修订、培训，与应用监督
·负责数据管理流程的不断改进与提升，保持公司在行业中处于数据管理先进地位
·负责具体项目的数据管理工作
·负责病例表及数据管理相关资料的交接，指导数据助理作详细记录
·审核项目数据管理计划、数据核查计划、核查程序
·审核项目疑问表的内容，并负责发出疑问表，督促疑问表回复情况
·参加项目的质量检查
·审核数据管理报告
·数据审核会议上作数据管理报告
·撰写统计分析人群划分决议
·组织项目的数据锁定工作
·审核项目归档文件
·配合部门管理工作
·配合部门经理协调部门内部的全面管理工作
·负责指导、监督商务助理的日常工作
·参与并具体负责员工的培训工作
·完成部门经理交办的其他工作

任职资格：
·教育背景：医学、药学、数据处理、数据录入或相关专业本科以上学历
·培训经历：GCP培训、公司SOP培训；数据管理、项目管理、团队建设与管理培训等
·经 验：完整操作3项(含)以上注册临床试验数据管理项目或具有3年以上临床数据研究经验，具有管理3人以上团队的工作经验。
·知 识：精通CRO、GCP相关行业知识；熟悉客户关系管理、项目管理
·技能技巧：能够熟练使用计算机软件；具有网络基础操作知识；具有熟练的英语应用能力
·个人素质：具有较强的逻辑思维能力、判断与决策能力、沟通能力、计划与执行能力；办事沉稳、细致，思维敏捷，有创新精神；优秀的职业素质和 品行，强烈的敬业精神与责任感

Job Description:
? Assist department manager to develop departmental working plan, and create annual plans and monthly plans for each job position;
? Track and manage the flow of project(s), including in-house data flow or electronic forms transfer;
? Study protocol and CRF design for project(s), and make out the key points, difficulties of data management, and develop solutions through team discussion;
? Serve as Data Operations Coordinator for one or two studies for proper resource allocation among projects;
? Confer with customers on variations in the project-specific schedule, if necessary;
? Serve in a leadership role to a specific DM task on all aspects of data management for project(s) such as data analysis and quality check(QC), CRF (eCRF) annotation, and data lock; and solve the problems encountered;
? Evaluate data acquisition processes & technologies, and suggest revisions to increase productivity and efficiency as well as accuracy of customer data;
? Contribute to the compilation, organization, production, promulgation and execution of SOPs, data quality goals and instruction manuals, data capture guidelines, forms for receiving, processing, or tracking data or other controlled documentation;
? Organize and develop project-specific data management plans & reports that address areas of data coding, reporting, or transfer, database locks, and work flow processes, etc., such as Data Management Plans and Quality Verification Plans, and Data Validation Procedures, data analysis listings and progress reports, to ensure accurate, timely, consistent, and qualified clinical data, and present some of them (needed) on the data checking meeting;
? Design and validate clinical databases including designing or testing logic checks;
? Monitor the compliance of information flows and data stores against data quality standards;
? Generate data queries based on validation checks or errors & omissions identified during data entry to resolve identified problems;
? Transfer CRF and other relevant materials and instruct a data assistant to record the whole process;
? Develop technical specifications for data management programming and communicate needs to information technology staff;
? Participate in the development of the clinical data model and/or database design;
? Supervise the work of data management project staff；
? Train data staff on technical procedures or software program usage;
? Provide support and information to functional areas such as marketing, clinical monitoring, and medical affairs;
? Provide data quality training and consulting services to others within the Company;
? Other tasks assigned by superiors.


Minimum Qualifications:
? Bachelor degree or above in pharmacy, medical science, data processing, data entry, or related specialties;
? Professionally trained in GCP, SOP, data management, project management, and team building & management;
? Rich experience in not less than 3 registered clinical trials, or over 3 years of experience in clinical data study, as well as experience or capability in leading teams of over 3 members;
? Theoretical knowledge of CRO industry, GCP policies, customer relationship management and project management;
? Good command of common computer software, skilled network operating and proficient in English communication;
? Excellent ability in logical analysis, judgment & decision-making, communication & coordination and planning & execution, dedicated & responsible attitude for work, as well as reliable, prudent and quick-minded character, innovative ethos, high professional quality and proper conduct.

注明：请以“姓名+专业+工作经验年限+申请职位”为邮件标题投递简历至hr@gcp-clinplus.com。

Company Overview

GCP ClinPlus Co., Ltd. (hereinafter referred to as GCP) is a combination of three well established companies: Beijing DMS Pharma Ltd., with CRO as its primary business; YiXie ZhongTai MedTech Consulting Ltd, committed to provide medical device product registration and relevant consultation; SMO unit, mainly engaged in Site Management Organization (SMO). All three companies are so mature and distinctive that they can take advantage of each other’s strengths.
GCP provides clinical research solutions which are customized and comprehensive, of international standards and making full use of various network and resources. The services of GCP, with the untiring effort of innovation and extending to new field, cover the evaluation and counseling of new drug R&D, regulatory affairs, clinical trial monitoring and management, data management, statistical analysis, medical affair and training, involving fields of pharmaceutical, biological product and medical device.
GCP is of a well trained professional team. All the operation team members have various professional backgrounds of clinical medicine, pharmacy or nursing etc. The management team is composed of group of senior people with deep knowledge of clinical medicine, pharmacy or biometrics and with rich experience of management. All of them have had over 10 years experience in various management positions in multinational pharmaceutical companies as well as famous CRO companies.
In early 2011, GCP signed the JV agreement with CMIC Co., Ltd. to enhance the capability and widen the geographic coverage. The win-win cooperation would surely enhance the core competitiveness and open a new chapter of accelerating development of GCP.


公司概况

普瑞盛（北京）医药科技开发有限公司由三家发展成熟，各具特色，优势互补的公司合并组成：以CRO业务为主体的北京迪美斯科技发展有限公司；提供全程医疗器械产品注册及咨询服务的医协众泰；以Site Management Organization (SMO) 业务为主体的博尔泰科。
普瑞盛致力于提供全方位的、符合国际标准的、充分利用人脉和地域资源的个性化临床研究解决方案。在坚持创新和拓展新领域的不懈努力下，普瑞盛的服务涵盖新药研发评估与咨询，注册事务，临床试验实施，数据管理和统计分析，医学事务及培训；业务范围涉及制药、生物技术和医疗器械等。
普瑞盛拥有一支富有拼搏精神的专业队伍，临床运营团队均具有临床医学、药学、护理学等背景；管理团队是由一批具有丰富临床医学、药学、生物统计学及管理学等经验丰富的资深人士组成，且皆拥有逾十年的跨国制药企业及著名CRO从业经历。
2011年初，普瑞盛（北京）医药科技开发有限公司引入外资，与日本希米科株式会社正式签定合资协议，成为中外合资企业。强手联合，增强了核心竞争力，揭开了快速发展的新篇章。

                                  律师声明

    近期，普瑞盛（北京）医药科技开发有限公司（以下简称“普瑞盛公司”）发现有不法分子冒用普瑞盛公司的名义，私刻人力资源部门的公函印鉴，公开发布虚假招聘、录用员工信息，给普瑞盛公司正常的人事管理工作带来了极大损害。
    北京市冠平律师事务所（以下简称“本所”）为普瑞盛（北京）医药科技开发有限公司（以下简称“普瑞盛公司”）常年法律服务支持机构，现根据普瑞盛公司的授权委托，由本所律师发表严正声明如下：
  1、任何以普瑞盛公司人事部印鉴形成的合同、入职邀请函等均为假冒侵权文件，凡持有上述文件的单位和个人，在本声明发布后，可与普瑞盛公司人力资源部门联系（电话:010-56088208），以确认相关事宜。
  2、普瑞盛公司已就上述侵权事件向属地公安机关报案，希望有关当事人立即停止侵权行为，消除不良影响。同时，郑重提醒愿望入职普瑞盛公司的个人，请直接与人力资源部门联系。
    3、本所律师已启动密切关注侵权者一切侵权行为的诉前程序，并将严格按照普瑞盛公司对事态发展的要求，保留进一步追究侵权者法律责任的权利。
  4、对任何与伪造普瑞盛公司人事部印鉴的持有者签订合同及进行业务往来的个人和单位，普瑞盛公司将不承担任何责任。受害个人和单位应直接到公安机关报案。

  特此声明！
                                                                         北京市冠平律师事务所穆华敏律师

                                                                                          2013年9月29日