Regional Clinical Research Manager, LCS China(职位编号:1559562)
通用电气(中国)有限公司 GE China
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:多元化业务集团公司 医疗设备/器械
职位信息
- 发布日期:2012-11-16
- 工作地点:无锡
- 招聘人数:1
- 工作经验:三年以上
- 学历要求:本科
- 语言要求:英语精通
- 职位类别:临床研究员
职位描述
Business Segment
Healthcare Systems
About Us
What do you envision for your future? At GE Healthcare, we strive to see life more clearly. Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing healthcare costs, increasing access and improving quality and efficiency around the world.
We are a $17 billion unit of General Electric Company (NYSE: GE), employing more than 46,000 people worldwide and serving healthcare professionals in more than 100 countries. We believe in our strategy - and we'd like you to be a part of it. As a global leader, GE can bring together the best in science, technology, business and people to help solve one of the world's toughest challenges and shape a new age of healthcare.
Something remarkable happens when you bring together people who are committed to making a difference - they do!
At work for a healthier world.
For more information about GE Healthcare join our LinkedIn Group: [url=http://linkd.in/p3Dqyk] GE Healthcare Global Community[/url] or visit our website [url=http://www.gehealthcare.com/careers]www.gehealthcare.com/careers[/url].
Role Summary/Purpose
GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation.The Research Manager for Life Care Solutions (LCS) in China will provide leadership of the clinical research responsibilities. He/she will partner with technology leaders, marketing leaders, and the Chief Medical Officer to ensure research strategies are aligned to meet the needs of the business. He/she will be responsible for coordinating the China research study workload across LCS business segments, interacting with business level General Managers, and will also have studies of his/her own
Essential Responsibilities
•Manage, mentor, coach employees on activities within areas of responsibility. (Team members may be co-located with the Research Manager or may be based in other facilities/countries.) •Plan, implement and drive all aspects of clinical studies in compliance with GCP, (Good Clinical Practice,) the RMP, (Research Management Procedure,) Work Instructions, Corporate Policies, guidelines and internal standards. •Manage, maintain and accurately forecast the research resource requirements •Partner with cross-functional team members, facilitating the ability to fulfill responsibilities in accordance with project specifications and regulatory, GCP and GEHC requirements. •Manage day-to-day operational aspects of assigned projects including third-party vendor activities. •Develop and maintain project milestones, timelines, budget and deliverables including project plans, trackers and tools for assigned projects. •Responsible for the timely and accurate completion of project documentation, such as protocols, amendments, case report forms and study report, stored appropriately and audit-ready. •Develop and maintain close working relationship with other Research Managers to ensure client satisfaction, operational and customer service excellence. •Manage, maintain and accurately forecast study requirements, clinical project subject enrollment and timelines, ensuring high level of data and image quality. •Interface with Regulatory Agencies as required. •Ensure overall regulatory compliance of investigational sites with applicable regulations. •Actively involved in Research process improvement activities/projects. •Actively involved in Corrective and/or Preventive actions tied to Research process. •Educate research team members on Good Clinical Practice guidelines, GEHC Research Management Procedure and applicable laws and regulations as they apply to research study. Quality Specific Goals: 1.Aware of and comply with Good Clinical Practice guidelines, the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. 2.Complete all planned Quality & Compliance training within the defined deadlines 3.Identify and report any quality or compliance concerns and take immediate corrective action as required. 4.Ensure Research is executed in compliance with Good Clinical Practices and other applicable regulations and company procedures. 5.Assist with continuous improvement activities by driving the implementation of process improvement initiatives.
Qualifications/Requirements
•Bachelor’s degree (or internationally recognized equivalent) in a natural/life science related field OR minimum of 12 years clinical trials experience, preferably including monitoring as a Sr. or Lead Clinical Research Associate, clinical auditing or clinical data management experience within the pharmaceutical or medical device industry. •Minimum 8 years clinical trials experience, preferably including monitoring as a Sr. or Lead Clinical Research Associate, clinical auditing or clinical data management experience within the pharmaceutical or medical device industry. •Minimum 3 year’s experience leading/supervising clinical research projects. •Demonstrated project management skills to prioritize, plan, delegate & evaluate deliverables; well organized and structured, attention to detail. •Excellent prior experience of all aspects of the clinical research process, including site selection, investigator qualifications, monitoring, protocol and report writing. •Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner. •Ability to travel up to 15% of time. Ability to travel domestically and internationally.
Desired Characteristics
•Master’s Degree (Natural/Life Sciences, Nursing) •Ability to communicate complex data to all levels of the organization from Business Leaders to individual project coordinators •Demonstrated problem solving, influencing and negotiation skills. •Demonstrated ability to work well in a team-oriented, collaborative environment. •Proven ability to multi-task, meet tight timelines and effectively partner with clients. •Experience interfacing with Global Regulatory Agencies such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc. •Prior medical device experience. •Auditing experience. •Clinical trial professional certification, e.g. CCRP, CCRA or CCRN •Excellence in organizing and leading segment/business planning initiatives to enable growth and clinical differentiation and/or solve key technology/patient/customer issues and/or engineering productivity and competency. •Excellent ability to develop, manage and execute clinical research, defining functional deliverables and critical dependencies.
公司介绍
GE公司的历史可追溯到托马斯?爱迪生,他于1878年创立了爱迪生电灯公司。1892年,爱迪生通用电气公司和汤姆森-休斯顿电气公司合并,成立了通用电气公司(GE)。GE是道 琼斯工业指数1896年设立以来唯一至今仍在指数榜上的公司。
2011年GE的年销售达1420亿美元。
GE现有6个产业部门,其中包括:航空、交通运输、医疗、能源、GE金融、家庭和商业解决方案。
GE (NYSE: GE) is Imagination at Work – an advanced global technology, service and finance company that is taking on the world’s toughest challenge. Widely recognized as the world’s largest multi-business company, GE excels in a variety of sectors including energy, oil and gas, water treatment, aviation, healthcare, transportation, lighting, appliances and finance. GE serves customers in more than 100 countries and employs more than 300,000 people worldwide. Jeffrey R. Immelt is Chairman of the Board and Chief Executive Officer of GE.
The company traces its beginnings to Thomas A. Edison, who established Edison Electric Light Company in 1878. In 1892, a merger of Edison General Electric Company and Thomson-Houston Electric Company created General Electric Company. GE is the only company listed in the Dow Jones Industrial Index today that was also included in the original index in 1896.
Total revenue of GE reached $142.0 billion in 2011.
GE is having six businesses including: Aviation, Transportation, Healthcare, Energy, GE Capital, Home and Business Solutions.
联系方式
- 公司网站:http://www.ge.com/
- 公司地址:华佗路1号
- 邮政编码:201103