上海招聘Study Start-Up(接受CRC和临床研究护士)

Study Start-Up(接受CRC和临床研究护士)

精鼎医药研究开发（上海）有限公司

公司规模：10000人以上
公司性质：外资(欧美)
公司行业：制药/生物工程

职位信息

发布日期：2019-04-01
工作地点：上海-浦东新区
招聘人数：若干人
工作经验：无工作经验
学历要求：招若干人
语言要求：不限
职位月薪：15-20万/年
职位类别：临床研究员

职位描述

主要负责临床项目启动工作，职位名称为Initiation Clinical Site Manager(临床研究中心经理,启动组)。

* 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 required Education* 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 language Minimum 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

公司介绍

精鼎医药（Parexel International）是全球领先的药物研究合同委托机构（CRO），总部位于美国生物医药圣地马萨诸塞州的波士顿附近，在世界各地拥有71个办事处，约17,600 名员工，为超过100个国家的客户提供服务。

精鼎医药成立于1982年，在三十多年的历程中，一直致力于发展成为全球生物制药和医疗器械行业首屈一指的新型医学疗法开发和商业化服务供应商，并且取得了卓越成果。目前，我们能够提供全世界CRO领域全面的新药临床阶段研发服务，服务内容包括新药开发策略的拟定与计划、国际临床试验规划执行及整合、临床试验的监测、临床试验数据处理、临床研究统计分析、临床试验总结及统计报告、临床试验稽核服务、临床试验供应和物流服务、临床电子数据采集、临床医学信息管理系统、新药查验登记事务和国际临床试验相关法规咨询等。

将我们的全球法规监管专业经验、I-IV期临床研究服务、整合的电子化临床技术能力和商业化服务结合在一起的一体化解决方案，可帮助我们的客户更加顺畅、经济和高效的推动整个研发历程。

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