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Specialist, Clinical Safety - Transcatheter Mitral and Tricuspid
Category: Health Care Industry
  • Your pay will be discussed at your interview

Job code: lhw-e0-74702420

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Edwards Lifesciences

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  Job posted:   Sun Jul 9, 2017
  Distance to work:   ? miles
  1 Views, 0 Applications  
Specialist, Clinical Safety - Transcatheter Mitral and Tricuspid
Edwards has a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. The candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use.


The Specialist, Clinical Safety assures adverse events are reviewed and handled in accordance with regulatory requirements (FDA, IRB, EC and Other Regulatory Bodies), and with EW procedures and ethical standards to ensure patient safety in clinical trials.

Essential Job Functions:

+ Analyze medical records received from enrolling sites to identify AEs (Adverse Events), SAEs (Serious Adverse Events) or UADEs (Unanticipated Adverse Device Effects) to confirm protocol definition and propose recommendations to site.

+ Develop and write medical narratives from multiple sources of adverse event reporting and/or complaint review forms in order to facilitate safety officers and CEC review in accordance to regulatory requirements, trial safety processes, and EW procedures.

+ Evaluate packets from source documents to ensure accuracy for event adjudication to CEC (Clinical Event Committee).


Required Education/Skills/Experience:

+ Bachelor's Degree in life sciences or related field required.

+ 3 years of previous hands-on clinical research related experience required.

+ Nursing background with focus on CVICU, Cardiac Cath Lab, Cardiovascular or Cardiac specialties strongly preferred.

+ Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification) preferred.

Other Required Skills:

+ Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g iMedidata).

+ Moderate knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies.

+ Experience with an ERP software (e.g JDE), CTMS (Clinical Trial Management System) and Patient Tracking system preferred.

+ Excellent written and verbal communication skills and interpersonal relationship skills.

+ Demonstrated problem-solving and critical thinking skills.

+ Substantial understanding of medical terminology as it relates to clinical safety.

+ Ability to manage confidential information with discretion.

+ Strict attention to detail.

+ Ability to interact professionally with all organizational levels.

+ Ability to manage competing priorities in a fast paced environment.

+ Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects.

+ Other incidental duties assigned by Leadership.

About Edwards

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.

Title: Specialist, Clinical Safety - Transcatheter Mitral and Tricuspid Therapies
Location: USA-USA-California - Irvine
Job Number: 011422

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