Job Function:
R&D Operations
Job Sub Function:
Clinical/Medical Operations
Job Category:
Professional
All Job Posting Locations:
Santa Clara, California, United States of America
Job Description:
Johnson & Johnson is hiring for a Sr. Field Clinical Engineer 6 Shockwave Medical to join our team. This role is fully remote within the United States.
Fueled by innovation at the intersection of biology and technology, we 27re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that 27s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
The Sr. Field Clinical Engineer is responsible for the development and execution of site-specific recruitment strategies that result in meeting enrollment targets for Shockwave Medical clinical trials.In addition, the Sr. Field Clinical Engineer will provide case support on Shockwave Medical products including Reducer and intravascular lithotripsy (IVL).The Sr. Field Clinical Engineer will play a critical role in clinical studies including device training, case support, and ensuring timely data collection for clinical programs.This work is accomplished with oversight, requires contact with internal stakeholders, frequent travel to clinical trial sites, works closely with physician advisors, and is critical to business success.
Essential Job Functions
Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices.
Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, including study protocol, instructions for use, core lab manuals and case report forms.
Provide clinical and technical support for key study investigators and clinical leaders at assigned sites.
Partner with other clinical research colleagues to meet business needs in the field including study start-up, site training, data collection for timely database locks and resolution of critical issues.
Administrative activities including training to procedures at site level.
Collaborate effectively with internal stakeholders (Clinical Affairs, Medical Affairs, Marketing and Medical Education) and external parties (vendors and physician advisors) to ensure Shockwave Medical clinical trials meet established enrollment goals.
Collaborate with internal and external stakeholders to develop a repository of recruitment/study awareness materials and tools.
Collaborate with internal and external stakeholders to ensure site-specific recruitment plans are implemented and progress tracked.
Develop and maintain strong relationships with site investigators and research staff to understand site recruitment and enrollment processes and resolve obstacles to enrollment to meet study goals.
Partner with assigned physician advisors to create and deliver recruitment strategies.
Partner with vendors that support recruitment activities.
Other duties as assigned.
Requirements
Bachelor 27s Degree in a scientific field of study or equivalent work experience.
Minimum of 5 years of relevant experience with at least 3 years of experience directly supporting interventional or surgical procedures within a hospital.
Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running investigational device exemption (IDE) trials.
Thorough knowledge of Good Clinical Practice (GCP) is required.
Ability to attain and maintain hospital credentials.
Ability to work in a fast-paced environment while managing multiple priorities.
Operate as a team and/or independently while demonstrating flexibility to changing requirements.
Experience with electronic data capture (EDC) systems.
Must have excellent verbal and written communication skills.
High attention to detail and accuracy.
Able to manage multiple project teams with guidance
Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.)
Must be able to travel approximately 80% mostly in the US and Canada, and potentially outside North America.
May be required to lift up to 25 pounds.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Clinical Operations, Clinical Research and Regulations, Clinical Trial Designs, Coaching, Communication, Ethical and Participant Safety Considerations, Innovation, Laboratory Operations, Office Administration, Preclinical Research, Problem Solving, Project Management, Project Schedule, Research and Development, Study Management
The anticipated base pay range for this position is :
$106,000.00 - $170,200.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company 27s consolidated retirement plan (pension) and savings plan (401(k)).
Please use the following language:
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
This position is eligible to participate in the Company 27s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation 6120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 648 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year
Holiday pay, including Floating Holidays 613 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave 6 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave 6 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave 6 80 hours in a 52-week rolling period10 days
Volunteer Leave 6 32 hours per calendar year
Military Spouse Time-Off 6 80 hours per calendar year
