天津招聘

Business Segment

Healthcare Quality

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Role Summary/Purpose

The Clinical Affairs Project Manager III is responsible for one or more clinical research (single or multi-center) studies. As the team leader, the Clinical Affairs Project Manager III will provide the study team with the overall direction, clear expectations for deliverables and the leadership necessary for the successful management, conduct and completion of a clinical study program.

Essential Responsibilities

• 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 cross-functional team, facilitating the team’s ability to fulfill their 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 metrics, 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 Research Manager to ensure client satisfaction, operational and customer service excellence. • Manage, maintain and accurately forecast study team requirements, clinical project subject enrollment and timelines, ensuring high level of data and image quality • Interfaces with Regulatory Agencies as required. • Ensures 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 GEHC research teams on Good Clinical Practice guidelines, GEHC Research Management Procedure and applicable laws and regulations as they apply to research study. • Effectively and succinctly communicate MACA organization mission/vision and value to business. 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

1. Bachelor’s degree (or internationally recognized equivalent) in a life sciences related field or R.N. plus a minimum of 4 years clinical research experience, OR a minimum of 8 years progressive experience with clinical research.2. Clinical Research experience to include of all aspects of the clinical research process, including: site selection; investigator qualifications; monitoring as a Sr. or Lead CRA; protocol and report writing; Clinical QA Auditing and/or Clinical Data Management within the pharmaceutical or medical device industry. (Medical Device research preferred.)3. Minimum 1 years’ experience leading/supervising clinical research projects, including managing teams and the ability to prioritize, plan, delegate & evaluate deliverables; is well organized and structured, strong attention to detail.4. Ability to travel up to 25% of time for job related responsibilities.

Desired Characteristics

1. Experience interfacing with Regulatory Agencies such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc.2. Clinical trial professional certification, e.g. CCRP, CCRA or CCRN3. Regulatory Affairs Certification (RAPS).4. Knowledge of Quality Management Systems (QMS).5. Strong problem solving, influencing and negotiation skills.6. Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner.7. Demonstrated ability to work well in a team-oriented, collaborative environment8. Experience working across cultures/countries/sites.9. Demonstrated experience effectively partnering with clients and prioritizing conflicting demands in an extremely fast paced environment.

通用电气（GE) 公司是一家全球领先的科技、服务和金融公司，是全球最大的多元化企业，致力于解决世界上最棘手的问题。GE的产品和服务范围广阔，从能源、石油天然气、水处理、航空、医疗、运输系统、家电、照明，到金融，客户遍及全球100多个国家，拥有30多万员工。杰夫?伊梅尔特先生是现任董事长及首席执行官。

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.