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. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.