临床研究科学家/clinical Research Scientist

面议 上海 经验不限 学历不限 全职
GE通用电气(中国)医疗集团 2017-07-21 更新 2017-09-23 截止

临床研究科学家/clinical Research Scientist

职位描述
Role Summary/Purpose
As Clinical Research Scientist the individual will have extensivecross-functional interaction within
the Company, ranging from R&D through to clinical, regulatory andcommercial functions. The role
holder will provide advice, council & support one or more strategicbusiness groups in truly
understanding the value of shrewdly designed and executed clinicaldevelopment plans across the
global businesses.
Essential Responsibilities
-To be responsible that project activities and milestones are planned,agreed and achieved
-To be responsible for the timely and accurate completion of projectdocumentation such as
protocols, amendments, case report forms and study reports, etc.
-Verifies scientific accuracy of safety and efficacy summaries forregulatory/ commercial purposes
and assists with the clinical sections of regulatory dossiers and orproduct specific scientific
discussion, depending on pre or post-marketing activities
-Responsibility for developing and maintaining the overall medicalstrategy of the assigned
product(s), for validating this strategy with appropriate internal orexternal experts and for agreeing
the strategy with the appropriate internal business stakeholders.
-To provide clinical leadership in cross functional project and productteams
-Working with the Quality Assurance and Regulatory Affairs teams toestablish and maintain
strong risk assessment and management processes for decision-making
-Input into Risk Management reviews as it relates to patient safety, theperformance of risk
assessment in the design of new products, and the interpretation ofpatient safety and risk in the
post-market environment.
-Collaborating with multiple functions to ensure patient safety,minimize risk, select products for
development with the greatest clinical unmet needs, work with teams andoutside experts to
design robust products and to support clinical research strategies forregulatory approval,
reimbursement and adoption
Quality Specific Goals:
1.Aware of and comply with the GEHC Quality Manual, Quality ManagementSystem, Quality
Management Policy, Quality Goals, and applicable laws and regulations asthey apply to this job
type/position
2.Complete all planned Quality & Compliance training within thedefined deadlines
3.Identify and report any quality or compliance concerns and takeimmediate corrective action as
required
4.Drive compliance/closure of Regulatory and Quality requirements beforeapproving Design
Control Functional Design Reviews and New Product Introduction programmilestones
5.Identify continuous improvement activities by initiating theimplementation of process and
product quality improvement initiatives
Qualifications/Requirements
1.Medical Degree or equivalent with relevant Clinical experience
2.Experience in GCP Clinical trials
3.Post –Graduate training or Medical experience in Radiology isdesirable
4.Good written and oral communication skills,
5.Ability to work independently and systematically
6.Good interpersonal skills to build good working relationships bothinternally and externally
7.Experience managing complex projects and/or across global regionsdesirable
8.A minimum of 5 years Medical Diagnostic (Cardiology) or Pharmaceuticalindustry experience
9.Excellent team player with global mindset
10.Prior experience working with Microsoft office products (Word, Excel,PowerPoint)
11.Must be willing to travel as required
Desired Characteristics
1.Excellent skills in written and verbal presentation
2.Board-certification in Neurology, Cardiology or Nuclear Medicine, withindustry experience
according to the overall clinical development plan, to include pre andpost marketing activities.
职位要求
  • 学历不限

  • 经验不限

工作地址

上海

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联系人
Zhang Fan fan.zhang1@ge.com
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