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Senior Manager, Clinical Patient Screening

Company: Edwards Lifesciences
Location: Irvine
Posted on: January 13, 2019

Job Description:

This is 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. We are looking for a passionate Clinical Affairs Senior Manager to support early-stage clinical new product development programs.
Responsibilities:

  • Oversee patient screening activities for multiple clinical studies for both tricuspid and mitral technologies
  • Manage a team that performs patient screening for feasibility and pivotal clinical studies supports clinical study start-up and study conduct activities collaborates with cross-functional teams in the continuing development of patient eligibility criteria manages imaging core laboratory activities
  • Maintains effective relationships with affiliate teams, vendors, and site research teams
  • Develop and implement processes to streamline activities, and ensures operational tracking tools are used to communicate progress metrics
  • Build a robust team and talent development plan#LI-PF1
    #MI
    Education/Qualifications:
    • Bachelor's degree in life science or related field
    • 12 years of previous related experience in medical device/ pharmaceutical/ biotech/clinical research/core laboratory industry
    • Knowledge of cardiovascular physiology and structural heart anatomy
    • Echo/Imaging highly desired
    • Prior clinical research experience with class II or III medical devices
    • Clinical research certification (ACRP or SoCRA / CRA certification)
    • Strong leadership/management skills required.
    • Well-developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.
    • Very strong project management skills
    • Good process development skills
    • Ability to manage competing priorities in a fast paced environment
    • Ability to build productive working relationships with internal and external partners
    • Demonstrated problem-solving and critical thinking skills
    • Knowledgeable in US and international medical device regulations, ICH and GCP guidelines
    • Proficient in MS Office Suite, electronic data capture systems, documentation management systems

      Keywords: Edwards Lifesciences, Irvine , Senior Manager, Clinical Patient Screening, Healthcare , Irvine, California

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