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Associate Manager, Clinical Safety - Transcatheter Heart Valve

Edwards Lifesciences LLC


Location:
Irvine, California 92614
Date:
06/13/2017
2017-06-132017-07-13
Job Code:
010386
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Clinical Operations
Edwards Lifesciences LLC
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Job Details

Edwards has an exciting opportunity in the Transcatheter Heart Valve (THV) group, focused on developing minimally-invasive solutions for patients suffering from structural heart disease.

 

As the Specialist, Clinical Safety, you will assure adverse events are reviewed and handled in accordance with regulatory requirements (FDA, IRB, EC and Other Regulatory Bodies), and with Edwards’ procedures and ethical standards to ensure patient safety in clinical trials.

 

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
  • Evaluate packets (compiled by lower level employees) from source documents to ensure accuracy for event adjudication to CEC (Clinical Event Committee)
  • 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

Requirements

Qualifications:

  • Bachelor's degree in biological or Lifesciences field 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
  • 8 years of previous hands-on clinical research and experience in an acute cardiovascular or critical care setting required

 

  • Proven successful project management skills
  • Proven expertise in MS Office Suite, Adobe, ERP software (e.g. JDE), CTMS (Clinical Trial Management System) and Patient Tracking system;  ability to operate general office machinery
  • Excellent written and verbal communication skills and interpersonal relationship Extensive knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies
  • skills including consultative and relationship management skills 
  • Demonstrated problem-solving and critical thinking skills
  • Extensive understanding of pre-clinical testing protocols, hospital environments and sterile techniques
  • Extensive understanding of medical terminology as it relates to clinical safety
  • Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g. iMedidata)
  • 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 serving as consultant to management.
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations