Clinical Scientist

Company: EBR Systems Inc
Location: Sunnyvale
Posted on: August 4, 2022

Job Description:

Description:
Silicon Valley-based EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. Heart Failure affects nearly 6 million people in the United States and more than 25 million globally. Some heart failure occurs due to conditions that cause the heart chambers to pump in a desynchronized manner, reducing the amount of blood pumped with each heartbeat. EBR's patented proprietary Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management. We are a team of dedicated individuals, driven to deliver superior treatment of millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective and reliable therapies using wireless cardiac stimulation. As a fast-paced company, every team member at EBR makes a big contribution towards our mission. We seek candidates who are passionate about improving healthcare and motivated to do the hard and exciting work required to bring a ground-breaking technology to market. The Clinical Scientist supports the company's mission of saving the lives of people undergoing cardiac resynchronization therapy by maintaining deep knowledge of both the clinical and quality functions. EBR Systems offers a great place to work as well as generous benefits and growth opportunities:

• Medical, dental, and vision insurance
• 401K
• PTO
• Competitive salary with opportunities for career growth
• Employee stock options
• 401(k) Bonus Program
• Life insurance Clinical Scientist Duties & Responsibilities:
  • Author documentation for US/OUS regulatory submissions, such as the Annual Progress Reports (APR), Clinical Evaluation Reports (CER), Post Market Clinical Follow-up (PMCF), and Clinical Study Reports.
  • Work with the data management team to understand the analysis and literature, and draft solid narratives for a diverse audience of scientists, clinicians, and regulatory bodies
  • Provide subject matter expertise on clinical safety, efficacy, marketability, and utility on data provided from clinical trials.
  • Participate in the development and construct of new clinical proposals by providing analysis and interpretation of market and inhouse clinical trial data.
  • Assist in the development of posters, manuscripts, abstracts, and literature for conference presentations.
  • Participate at conferences, vendor shows, and regulatory body meetings/calls as needed.
  • Assist in the development study protocols, case report forms (CRFs), informed consent forms (ICFs), and other applicable study documentation used in current and new study protocols.
  • Collaboratively works, builds, and maintains effective working relationships cross-functionally with internal clinical teams in the execution of the study to achieve study goals and milestones.
  • Regularly communicates with Clinical Management and other senior management regarding study status, identifying study gaps, issues, and risks. Requirements:
    Education & Experience:
    • Bachelor's Degree required; Master's Degree preferred
    • 3 to 5 years of experience in a clinical environment or medical device industry; specific cardiovascular device experience is preferred.
    • Experience authoring new study protocols, CRFs, ICFs, Reports, and other applicable study materials for clinical trial use.
    • Experience writing Annual Progress Reports (APR), Post-Market Clinical Follow-up (PMCF) Reports, Clinical Evaluation Reports (CER), and Clinical Study Reports with a good understanding of clinical trial operations, clinical trial logistics, and Good Clinical Practices.
    • Experience operating effectively within a medical/biotech start-up with complex studies; ability to prioritize tasks and manage multiple priorities and meet deadlines.
    • Experience using Veeva Vault eTMF and IBM Clinical Development (eCRF) is a plus.
    • Experience and facile with web-based EDC, software tools (Microsoft Office Suite), Adobe, SharePoint, ShareDrive, and other custom web-based software used for administrative functions Qualifications:
      • Ability to review scientific literature and data reports to form summary narratives.
      • Knowledge of regulatory standards (ICH, GCDMP, 21 CFR 11, GDPR)
      • Excellent writing skills a must PI184791663

Keywords: EBR Systems Inc, Sunnyvale , Clinical Scientist, Healthcare , Sunnyvale, California