Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Job Function: Data Analytics & Computational Sciences Job Sub Function: Clinical Data Management Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Sr. Clinical Data Manager – Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US. We are developing the next generation of smarter, less invasive, more personalized treatments, including pioneering the development and commercialization of Intravascular Lithotripsy (IVL) for complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease with sonic pressure waves for calcified plaque. Position Overview The Sr. Clinical Data Manager oversees global data management activities throughout the clinical study lifecycle. Responsibilities include managing data activities, vendor oversight, and ensuring compliance with regulatory standards, aligned with Shockwave Medical Inc.'s business needs. The role involves collaboration within a multidisciplinary team for pre- and post-market medical device studies, handling multiple projects or programs. Essential Job Functions Manage and monitor data management activities with CROs or vendors; build effective relationships. Develop and execute data management plans, case report forms, databases, data specifications, edit checks, query logic, user acceptance testing, and data validations. Lead data management activities following established standards, including vendor data reconciliation, medical coding, protocol deviation collection, and query management. Collaborate with Clinical Affairs and Biostatistics to streamline clinical study metrics and review processes. Review clinical research documents such as study protocols, investigator brochures, and clinical study reports. Ensure data quality in EDC for reviews, DSMBs, and database locks. Assist in reconciling adverse event data in safety and clinical databases. Coordinate archiving of study databases and documents. Mentor and train junior team members. Propose and lead process improvements. Perform other duties as assigned. Requirements Bachelor’s Degree in a scientific field preferred. Minimum 5 years supporting clinical research or relevant scientific experience. Experience supporting device pre- and/or post-market studies, including IDE trials preferred. Thorough knowledge of GCP. Ability to manage multiple priorities in a fast-paced environment. Teamwork and independence with flexibility to changing requirements. Experience with data collection, EDC systems, and related tools. Understanding of cardiovascular disease and therapies is an advantage. Excellent communication skills and cross-functional experience. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other protected characteristics. We seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. If you require accommodations during the interview process due to a disability, please contact the Employee Health Support Center or AskGS. Pay Range The anticipated base pay range for this position is: US: $89,000 - $143,750; Bay Area: $103,000 - $165,600. Additional benefits include performance bonuses, health insurance, retirement plans, and paid time off. More details can be found at . #J-18808-Ljbffr Johnson & Johnson

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