Initiation Clinical Site Manager(项目启动专员)招聘_精鼎医药研究开发（上海）有限公司最新招聘信息-猎才医药网

职位描述

* Conduct country specific feasibility and/or site pre-qualification* Review and validate site identification list* Collect and negotiate Confidentially Agreements (CDA) as required* Organize translations per country/regulatory/client requirements* Review and approve country specific and/or site specific documents or essential regulatory documents (SRP)* Customize, review, configure, and negotiate as required country/site specific Informed Consent Forms (ICF) and their amendments* Prepare and submit IRB/IEC application and follow up until final approval received (initial submission and amendments)* Prepare and negotiate as required initial and/or amended CSA at a site level* Resolve CSA changes requested by the site and approve any change in CSA language with support from Site Contract Leader (SCL) as required* Collect internal CSA signatures* Complete routine departmental administrative tasks in an accurate and timely manner (e.g. timesheets, metrics, etc.)* Proactively keep manager informed about work progress and any issues (including conflicting priorities and free capacity)* Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL training requirements, and study specific procedures and training* Ensure excellent understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and efficient delivery* Update all appropriate Clinical Trial Management systems (CTMS) as indicated per function on an ongoing basis and submit all relevant documents to central files per the Central File Maintenance Plan* Escalate any site and study issues that require immediate action to the Functional Lead (FL)* Proactively work with other project team members to meet project goals* Show commitment and perform consistent high quality workIn addition;* Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner* Manage complex sites and protocols across multiple therapeutic areas with a high level of autonomy* Provide input to country selection strategy* Support less experienced staff on project assignments as appropriate* Recognize out of scope activities and communicate to FL* Anticipate impact of issues/delays/changes on study timelines and communicate to FL* Participate in internal audits/client meetings with minimal supervision* Proactively inform manager about work progress and any issues to avoid unforeseen situations and recommend solutions* Require minimal supervision by Manager* Act as functional/technical Subject Matter Expert (SME) as required* Identify inconsistencies and inefficiencies in processes/systems/trainings and recommend solutions* Participate in internal and external process improvement initiatives*Job Qualifications* Excellent presentation skills* Client focused approach to work* Ability to interact professionally with external customers* Flexible attitude with respect to work assignments and new learning* Advanced ability to manage multiple and varied tasks with enthusiasm* Attention to detail* Ability to work in a matrix and virtual team environment and to value the importance of teamwork* Strong computer skills including but not limited to the knowledge of Clinical Trial Management Systems (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word* Excellent interpersonal, verbal, and written communication skills* Advanced problem solving skills* Sense of urgency in completing assigned tasks* Excellent time management in order to meet daily metrics, team objectives and department goals* Proven ability to work across cultures* Excellent ability to work independently but seek guidance when necessary* Excellent ability to influence and negotiate resolutions and outcomes with sites and IRBs/IECs* Willing and able to travel locally and internationally occasionally as requiredEducation* Educated to degree level (biological science, pharmacy, or other health-related discipline preferred), nursing or other relevant qualification/experienceLanguage Skills* Excellent written and oral English and fluent in relevant local languageMinimum Work Experience* Substantial previous clinical trial start-up experience or equivalent experience in clinical research with strong understanding of clinical trials methodology and terminology 职能类别：临床研究员

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！

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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