Sr. Clinical Data Manager - Shockwave Medical

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 https://www.jnj.com

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.

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 https://www.jnj.com/.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio 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 directl