Clinical Scientist
Company: EBR Systems Inc
Location: Sunnyvale
Posted on: August 4, 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 preferred3
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 mustPI184792111SDL2017
Keywords: EBR Systems Inc, Sunnyvale , Clinical Scientist, Healthcare , Sunnyvale, California
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