Clinical Scientist
Company: EBR Systems Inc
Location: Sunnyvale
Posted on: May 15, 2022
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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 insurance401KPTOCompetitive salary with
opportunities for career growthEmployee stock options401(k) Bonus
ProgramLife insuranceClinical 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
bodiesProvide 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 functionsQualifications: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 PI177584917
Keywords: EBR Systems Inc, Sunnyvale , Clinical Scientist, Healthcare , Sunnyvale, California
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