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
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