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.

The Sr. Clinical Research Associate (Sr. CRA) will be responsible for establishing, managing and meeting milestones of clinical studies in compliance with applicable clinical and regulatory standards and in alignment with business needs. They will be accountable for clinical project management activities, for coordination with cross-functional counterparts and contract research organizations (CROs) in global studies. This position requires strategic, project and resource management responsibilities for the assigned clinical program(s) to evaluate the safety and effectiveness of interventional products. This work is accomplished with moderate supervision and requires a motivated, self-starter who can work independently once projects are assigned.

• Participate in the design and execution of global studies for regulatory submissions, reimbursement and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management.
• Manage study preparation, activation, enrollment, submission, maintenance and closure activities.
• Participate in administrative activities associated with the clinical department including procedures, training of key personnel and preparation and maintenance of objectives and budgets.
• Interface with representatives from key functional groups to drive product development within core teams, and clinical wide or cross-departmental initiatives.
• Ensures appropriate oversight of clinical study by internal and external resources including, but not limited to monitoring staff, CROs and core laboratories.
• Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders.
• Negotiate contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliers.
• Supervise training of investigators, site staff and field clinical staff.
• Evaluates clinical and adverse event data during the conduct of the study and for completion of clinical study reports and other technical documents.
• Ensures quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actions.
• Regularly communicates study status to senior management and represents organization to key customers.
• Other duties as assigned.

• Bachelor's Degree in a scientific field of study with a minimum of 5 years' experience directly supporting clinical research
• Working knowledge of Good Clinical Practice (GCP), FDA, ISO and other applicable regulations)
• Knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting
• ACRP or SOCRA clinical research certification preferred
• Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
• Ability to travel up to 25% domestically and internationally
• High attention to detail and accuracy
• Computer skills (MS Office products, word processing, spreadsheets, etc.)
• Finance and budgeting knowledge
• Good prioritization and organizational skills
• Excellent critical thinking skills
• Excellent influencing and negotiation skills
• High energy and results-oriented individual who is mature and successful in a business environment
• Proactive and "can do" attitude
• Works effectively on cross-functional teams
• Effective written, verbal and presentation skills with all levels of management and organizations
• Operates both as a team and independently, with adaptability to changing requirements
• Ability to work in a fast-paced environment, managing multiple priorities

Market Range: $92,000 - $114,000
Exact compensation may vary based on skills, experience, 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