临床研究科学家/clinical Research Scientist

Role Summary/Purpose
As Clinical Research Scientist the individual will have extensivecross-functional interaction within
the Company, ranging from R&D through to cl******** regulatoryan******** functions. The role
holder will provide a******** council & support one or morestrategic business groups in truly
understanding the value of shrewdly designe******** execute********development plans across the
global businesses.
Essential Responsibilities
-To be responsible that project activities an******** are planned,agree******** achieved
-To be responsible for the timely an******** completion of projectdocumentation such as
protocols, amen******** case report forms an******** reports, etc.
-Verifies scientific accuracy of safety an******** summaries forregulatory/ commercial purposes
an******** with the clinical sections of regulatory dossiers an********product specific scientific
******** depending on pre or post-marketing activities
-Responsibility for developing an******** the overall medical strategyof the assigned
product(s), for validating this strategy with appropriate internal orexternal experts an******** agreeing
the strategy with the appropriate internal business stakeholders.
-To provide clinical leadership in cross functional project an********teams
-Working with the Quality Assurance an******** Affairs teams toestablish an********
strong risk assessment an******** processes for decision-making
-Input into Risk Management reviews as it relates to patient safety, theperformance of risk
assessment in the design of new pro******** an******** interpretation ofpatient safety an******** in the
post-market environment.
-Collaborating with multiple functions to ensure patient safety,minimize r******** select products for
development with the greatest clinical unmet nee******** work with teamsan******** experts to
design robust products an******** support clinical research strategiesfor regulatory approval,
reimbursement an********
Quality Specific Goal********
1.Aware of an******** with the GEHC Quality Manual, Quality ManagementSystem, Quality
Management Pol******** Quality Goals, an******** laws an******** as theyapply to this job
type/position
2.Complete all planne******** & Compliance training within thedefine********
3.Identify an******** any quality or compliance concerns an********immediate corrective action as
required
4.Drive compliance/closure of Regulatory an******** requirements beforeapproving Design
Control Functional Design Reviews an******** Product Introductionprogram milestones
5.Identify continuous improvement activities by initiating theimplementation of process and
product quality improvement initiatives
Qualification********
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.Goo******** an******** communication sk********
5.Ability to work independently an********
6.Goo******** skills to buil******** working relationships bothinternally an********
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
Desire********
1.Excellent skills in written an******** presentation
2.Board-certification in Neurology, Cardiology or Nuclear Me********with industry experience
according to the overall clinical development plan, to include prean******** marketing activities.