衡阳招聘

Job Summary职位概述:

1.This position is to support, establish and oversee the QMS framework effectiveness in MRA clinical operation activities. S/he drives/enables the MRA clinical operation quality system and risk management culture and enables the clinical trials perform to the highest standards.

该职位协助，建立和监督MRA临床操作活动中的QMS框架有效性。他/她推动/启用MRA临床操作质量系统和风险管理文化，并使临床试验达到***标准。

Main Tasks & Responsibilities主要工作职责 :

1.Establish/support development and oversee QMS framework effectiveness to enable high quality standards in MRA clinical trials and drive clinical operation inspection readiness program.

建立/支持发展和监督QMS框架的有效性，以便在MRA临床试验中实现高质量标准并推动临床操作检查准备计划。

2. Drive the quality mindset culture in MRA clinical operation activities.

在MRA临床操作活动中推动质量思维文化。

3.Oversee and provide guidance and expertise to local clinical operation to enable clinical process, system, orientation and training activities in MRA are aligned with Roche policies, directives, SOPs, industry best practices and standards, international and/or local regulations and/or requirements.

监督当地临床操作，并为其提供指导和专业知识，使MRA的临床过程、系统和培训活动与罗氏政策、指令、SOP、行业***实践和标准、国际和/或当地法规和/或要求相一致。

4.Provides guidance and expertise to clinical operation team on clinical operation process, system, training, quality standard and risk management matters. Be a subject matter expert (SME) and provide consultation on the clinical operation process, system and training matters; coordinate, manage, maintain, track and/or control the MRA clinical operation Quality Documents; support maintenance of clinical operation orientation and training matrix, design and deliver training program as needed; collaborate with key stakeholders and managers (as apply) to oversee the clinical operation staffs training compliance matrix, status and ensure all staffs are appropriately trained on the clinical operation process and system; oversee the status and coordinate/manage the MRA annual clinical activity Inspection Readiness.

为临床团队提供有关临床操作流程，系统，培训，质量标准和风险管理事宜的指导和专业知识。作为临床操作流程，系统和培训的专家 (SME)并提供临床事宜咨询， 协调，管理，维护，跟踪和/或控制MRA临床操作质量文件; 支持维护临床操作方向和培训模型，根据需要设计和提供培训计划; 与主要利益相关者和管理者（如适用）合作，监督临床操作人员培训合规性指标，状态并确保所有员工接受适当的临床操作流程和系统培训; 监督状态并协调/管理MRA年度临床活动检查准备情况。

5.Oversee and escalate to management team for decision/action (if apply) on the overall health status and metrics of clinical operation process, system, training and quality risk management and/or implementation.

监督并向管理团队报告，以便就整体健康状况和临床操作流程，系统，培训和质量风险管理和/或施的指标做出决策/行动（如适用）。

6.Liaise with multiple functions to support the development and drive the local operation adoption of the IT tools and the processes and systems trainings, as apply.

如适用, 与多个部门同行保持联系，以支持发展并推动IT工具的本地运营采用以及流程和系统培训。

7. Participates in the organization improvement initiatives and cross-departmental projects or act as external contact window for MRA clinical operation Process & Training area (as apply).

参与组织改进计划和跨部门项目或作为MRA临床操作过程和培训区域的外部联系窗口 (如适用)。

8.If apply, develop and maintain a good working relationship with BAs and other dept. to support the cross functional projects.

如适用， 开拓并维护与业务部门和其他部门的良好工作关系，以支持跨部门项目。

9. Other projects or tasks assigned by line manager.

主管指派的其他任务

10. Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection.

遵循罗氏所有合规要求，包括但不限于罗氏信息安全，罗氏商业中的行为，罗氏竞争法互动对话，罗氏安全健康环境等，合法合理开展业务活动。

11. Understand and fulfill the responsibility of line manager's SHE tasks and duties (as defined in SHE handbook).

了解并执行直线经理的SHE职责（详见SHE手册相关定义）。

Basic Requirements of the Job基本任职资格:

Education& Qualifications教育背景与专业资格:

1. At least Bachelor degree in medical science, preferably in clinical medicine, medical laboratory, bio-statistics, pharmacology, and biology

医学科学相关专业本科及以上学历，临床医学、医学检验、生物统计、药学、生物学优先

2. Proficiency in both spoken and written English

熟练掌握英语口语及书面表达

3. Good command of MS office software application

熟练应用微软办公软件

4. Understand pharmaceutical and/or medical device regulation and ICH/GCP

了解药品及/或医疗器械法规和ICH/GCP

Experience工作经验:

1.At least 3years of working experience in clinical research, clinical project management, training, clinical quality assurance, biostatistics, data and document management in clinical medicine, pharmaceutical, Medical Device, or in-vitro Diagnostics industry

3年以上临床医学、制药、医疗器械或体外诊断行业内临床研究、临床项目管理、培训、临床试验质量保证、生物统计、或数据和文档管理相关工作经验

2. 1-2 years of project management or people management experience is a plus but not prerequisite.

1-2年的项目管理或人员管理经验尤佳，但不是先决条件

3. Highly effective oral and written communication skills; able to get ideas across face-to-face, in group settings as well as in presentation

高效的口头及书面沟通技巧; 能够在面对面，小组设置和演示中获得想法

Values & Core Competencies 价值观与核心能力：

1. Demonstrate Roche values of Integrity, Courage, Passion

体现罗氏的价值观：真诚,勇气,激情

2.The Core Competencies is identified as being most crucial for success in this role please refer to “Roche China University Website - Career Development - Platform”

关于这个角色成功最重要的核心能力, 具体细节请参考 “罗氏中国大学网站 – 职业发展 – 发展平台”

北京外企德科人力资源服务上海有限公司（简称 FESCO Adecco 外企德科）是中国人力资源服务行业具竞争力和品牌价值的FESCO与全球人力资源服务行业领航者Adecco成立的一家中外合资人力资源服务企业，为企业及个人提供业务外包、人事服务、招聘猎头和员工福利等相关人力资源解决方案。

成立于1979年，FESCO拥有悠久的人力资源专业化服务历史、丰富的市场经验以及完备的服务资质，是中国人力资源服务行业的领跑者，Adecco则是全球人力资源行业的巨头，服务网络遍布全球60多个国家和地区。FESCO Adecco成立后，双方通过优势互补，整合了客户资源，依托全球化的资源和服务平台，融合本土网络优势，扩大了业务范围，为客户提供全方位的业务流程外包（BPO）、财务外包与薪酬管理、人事委托/人事派遣、全球化派遣、人才招聘/RPO相关服务、健康福利与弹性福利等人力资源解决方案。合资后的FESCO Adecco飞速发展，并且在浙江、重庆、深圳、苏州设立了分支机构。目前，FESCO Adecco在中国每天服务达100万名员工，服务客户近12,000家。

FESCO Adecco致力于成为***的人力资源全面解决方案提供商，成为客户最值得信赖的人力资源合作伙伴。为客户打开通向国际市场及创新型人力资源服务模式的大门，推动中国乃至全球的人力资源外包产业的健康发展。