United Spinal Association Jobs

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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. Position Overview The Sr. Clinical Data Manager is responsible for the oversight of global data management activities across the clinical study life cycle. The individual will be accountable for data management activities, oversight of multiple vendors, and for conducting studies in compliance with regulatory standards and in alignment with Shockwave Medical Inc.'s business needs. The individual will participate as an active member of a global multi-disciplinary team to execute the Data Management tasks required for pre and post market medical device studies. The Sr. Clinical Data Manager has a broad, fundamental knowledge of the data management process and is responsible for multiple clinical projects or programs. Essential Job Functions Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts. Development and execution of data management plan, case reports forms, database development, data specifications, edit checks, query logic, user acceptance testing, and data validations. Lead data management activities in adherence with established standards including third party vendor data reconciliation, medical coding processing, protocol deviation collection, query management to identify errors and inconsistencies in clinical data and ensure their resolution. Partner within Clinical Affairs and Biostatistics to streamline metrics related to clinical study execution and refine clinical data review processes to ensure oversight of clinical studies. Participate in the review of Clinical research documents including study protocols, investigator brochure, and clinical study reports as necessary. Work collaboratively with Clinical and Biostatistics to ensure data in EDC is of quality for Data Reviews, DSMBs, and interim or final database lock. Assist in reconciling adverse event data in Safety and Clinical databases. Coordinate the archiving of study databases and related documents. Mentor, train, and oversee tasks of junior or new team members. Proactively suggest process improvements and effectively lead the implementation of action items. Other duties as assigned. Requirements Bachelor's Degree, preferably in a scientific field of study Minimum 5 years' experience directly supporting clinical research or relevant experience in medical/scientific area. Knowledge and experience in supporting device pre- and/or post-market clinical studies, including IDE trials preferred. Thorough knowledge of Good Clinical Practice (GCP) 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 various data collection and Electronic Data Capture (EDC) systems and related tools and processes. A proficient understanding of cardiovascular disease and therapies is an advantage. Detail oriented with excellent communication skills and extensive experiences working in cross-functional setting. Market Range: $102,000 - $151,000 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