Clinical Scientist

  • Edwards Lifesciences
  • Irvine, CA, USA
  • Jul 20, 2020
Full time Health Care

Job Description

The Clinical Scientist is responsible for providing scientific expertise throughout the development and implementation of clinical evaluations and /or clinical studies for a dynamic portfolio of product. 

As a key member of the Medical Affairs, Clinical Science & Biometrics team, this individual will provide scientific expertise in the development of clinical trial strategy, clinical study design, clinical evaluation reports, clinical study protocols, risk management, and /or clinical studies in alignment with the business strategy. Through extensive interaction with clinician thought leaders (KOLs) along with a strong diverse cross-functional leadership team within the organization, this individual will have opportunities to make strategic and scientific impact on our current and future clinical portfolio.  

Key Responsibilities:

  • Authors clinical evaluation plans (CEP), clinical evaluation reports (CERs), clinical trial protocols (pre- and post-market) and other scientific documents (as appropriate).  
  • Partner with R&D, Clinical Affairs, Safety, Regulatory Affairs, QA, Biometrics, GHER and other subject matter experts to create documents and that effectively and clearly describe research results, product use and other medical information.
  • Provide scientific support by interpreting safety and effectiveness results data, including data mining, compiling, analyzing and summarizing data from all applicable sources
  • Maintain current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge.
  • Collaborate with cross functional teams on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting
  • Independently review raw and summary data for accuracy.
  • Summarize key clinical evidence from published literature and provide updates to internal stakeholders (as appropriate)
  • Correctly analyze clinical data/results and interpret outcomes to propose appropriate follow-up.
  • Ensure documents comply with regulatory guidelines.
  • Up to 15% travel to conferences/physician meetings.

Education and Minimum Requirements:

Bachelor's Degree or equivalent with 5 years of clinical science experience.

Preferred Qualifications:

Relevant experience supporting class III medical devices

Additional Talents and General Expectations:

  • Experienced with literature reviews and various publication databases including PubMed. 
  • Strong analytical, problem-solving, and scientific writing skills
  • Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously
  • Excellent oral and written communication skills 
  • Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote and Adobe Acrobat

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.