Senior Clinical Research Associate

Shockwave Medical Fremont, CA

About the Job

Shockwave Medical is revolutionizing the interventional treatment of advanced cardiovascular disease, creating new opportunities for patients and physicians by effectively targeting calcified plaque. Together, we are working to reshape interventional therapy with Lithoplasty® Technology for the treatment of calcified plaque. The Senior Clinical Research Associate is responsible for establishing, managing and meeting milestones of clinical studies in compliance with applicable clinical and regulatory standards and in alignment with business needs. This candidate is 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. Requirements + 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 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. Requirements + Minimum Bachelor’s Degree in a scientific field of study. + Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials. + Minimum 5 years’ experience directly supporting clinical research or relevant experience in medical/scientific area. + 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. + Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology. + Ability to travel 30-40% 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. + Entrepreneurial “hands-on” experience. Pro-active and “can do” attitude. + Works effectively on cross-functional teams. + Effective written, verbal and presentation skills with all levels of management and organizations. + Operate both as a team and independently, with adaptability to changing requirements. + Ability to work in a fast paced environment, managing multiple priorities. + There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Benefits Shockwave Medical offers competitive salary, equity and healthcare. If you have experience and initiative for this fast paced fun start-up, please apply. EEO Employer