丁香人才 > 职位招聘 >医药公司/药店/医疗器械招聘 >其他招聘 >上海其他招聘 >Clinical Affairs Manager招聘

Clinical Affairs Manager

美敦力中国 2016-12-06发布 2017-07-04截止
该职位同时在北京 招聘,欢迎申请。
  • 学历要求: 不限
  • 外语要求: 不限
  • 年龄要求: 不限
  • 专业要求: 不限
  • 工作年限: 不限
  • 月薪范围: 面议
  • 职位性质: 全职
  • 工作地点: 上海市
  • 职称要求: 不限
  • 招聘人数: 若干

职位描述

Job Description:
• Oversee all operational aspects of multiple clinical research programs, to support corporate and departmental objectives.
• Provide direction, development, subject matter expertise and support to Clinical Project Manager, Clinical Research Associates, and Contract Research Organization(s) as needed
• Drive Evidence Based Medicine Strategies are developed and executed.
• Ensure clinical research programs are conducted in accordance with company standard operating procedures (SOPs), Good Clinical Practice (GCP), and specific country regulations, as applicable.
• Write clinical protocols for domestic and international submission.
• Oversee development of project plans, program budgets and study tracking tools.
• Assist in data analysis and preparation of clinical reports.
• Develop training materials for clinical affairs personnel.
• Participate in organizing and planning of investigator meetings.
• Oversees and participates in in-country and international clinical affairs program activities including but not limited to CFDA strategy meetings, Regulatory CER submission, preparation and review.
• Ensure appropriate recruitment / selection investigational sites to participate in clinical studies.
• Prepare periodic reports for senior management review.
• Assist investigators in preparation of applicable publications.
• Attend study procedures to ensure protocol compliance and provide device support as needed.
• Serve as technical resource to investigators, sales representatives, and other staff members regarding investigational products and protocol.
• Gather input from cross-functional teams and create plans that help the team produce deliverables on schedule.
• Provide clinical and technical feedback to design and development groups.
• Assume supervisory responsibility as needed. May be directly responsible to manage Clinical Research Associates.
• Recruits staff members, conducts performance appraisals, and fulfills other managerial responsibilities as necessary.
• Perform other clinical duties when requested.


Education and Experience:
• A minimum of a Medical degree or Bachelor’s Degree in Life Science (Animal Science, Biology, Physiology, Nursing, Medical Technology) plus seven (7) years relevant experience, which includes a minimum of three (5) years’ experience in medical device/drug clinical research, and a minimum of (2) years experience managing (indirectly or directly) a professional staff.
• Master’s degree with a demonstrated research background is preferred.
• Experience with Good Clinical Practice (GCP) is required. Knowledge of Good Laboratory Practice (GLP) and Good Manufacturing Procedures (GMP) will be an advantage.
• Prior participation in all facets of clinical studies and prior supervisory experience required.
• Strong technical or clinical background required.
• Administering successful programs within a timeline
• Effective communication on superior, peer, and subordinate levels
• Ability to hire quality professionals
• Demonstrated leadership to develop, motivate and guide subordinates to meet objectives

• Effective written and verbal communication skills in the area of technical/clinical applications. Strong command of medical and surgical terminology.
• Demonstrated ability to persuasively influence external medical professionals to ensure project deliverables are completed on time and within budget.
• Effective analytical and problem solving.
• Ability to coordinate and lead multiple projects simultaneously.
• Knowledge of CFDA regulations concerning the conduct of pre-clinical, clinical studies and CER submissions.
• Knowledge of local, regional, and international regulations for clinical studies is preferred.
• Effective knowledge in searching medical literature and databases for clinical and technical information.
• Familiarity with biostatistics techniques and methods is an advantage.
• Effective skills in MS Excel, PowerPoint, Word and internet search engines.
• Excellent computer skills and knowledge of computerized databases for the maintenance of scientific data.
• Working knowledge of statistics and statistical methods.
• Strong command of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations.
• Ability to train others.
• Ability to work with a minimum of supervision.
• Ability to work in a highly matrixed team environment.
该单位 HR 近两周的应聘简历处理率: 20%

联系人: Elaine Xu

地    址:上海市

美敦力中国-美敦力(上海)管理有限公司
About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries. ...详情

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