Clinical Site Manager Jobs

Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. With the recent acquisition of Neovasc and their innovative Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina – long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide. Together, we are working to bring these patients relief from their symptoms and hopefully improve their quality of life.

Position Overview

The Clinical Site Manager (CSM) 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 CSM will provide case support on Shockwave Medical products including Reducer and intravascular lithotripsy (IVL). The CSM 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 minimal 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

• Other duties as assigned.
• Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices.
• Leads study awareness activities that may include participation at clinical sites, congresses, and other meetings.
• This role will 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.
• Develops and maintains strong relationships with site investigators and research staff to understand site recruitment and enrollment processes and resolve obstacles to enrollment to meet study goals.
• Administrative activities including training to procedures, manage territory travel and budgets.
• 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.
• Partners with vendors that support recruitment activities.
• Collaborates with Sr. Manager of Clinical Trial Recruitment, and other internal and external stakeholders to develop a repository of recruitment/study awareness materials and tools.
• Partners with physician advisors to create and deliver recruitment strategies.
• Collaborates with internal and external stakeholders to ensure site-specific recruitment plans are implemented and progress tracked. Reports overall recruitment metrics to leadership.
• Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
• Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, inclining study protocol, instructions for use, core lab manuals and case report forms.

Requirements

• Minimum of 8 years of experience directly supporting interventional or surgical procedures within a hospital.
• Must have excellent verbal and written communication skills.
• Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running investigational device exemption (IDE) trials.
• May be required to lift up to 25 pounds.
• Bachelor’s Degree in a scientific field of study.
• 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.
• Able to manage multiple project teams.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day)
• Experience with electronic data capture (EDC) systems.
• High attention to detail and accuracy.
• Ability to work in a fast-paced environment while managing multiple priorities.
• Thorough knowledge of Good Clinical Practice (GCP) is required.

Market Range: $131,300 - $136,755
Exact compensation may vary based on skills, expertise, and location

Benefits

Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks -

Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance

Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer #LI-BR1 #LI-REMOTE