Clinical Research Manager - Shockwave Medical (Remote)

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:
R&D Operations

Job Sub Function:
Clinical Trial Project Management

Job Category:
Professional

All Job Posting Locations:
Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Clinical Research Manager - Shockwave Medical (Remote) 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/.

Position Overview

The Clinical Research Manager is responsible for the day-to-day management of a global clinical study.

The Clinical Research Manager will be accountable for project management activities, oversight of multiple vendors and for conducting a global clinical study in compliance with applicable clinical and regulatory standards and in alignment with the business needs.

This work is accomplished with minimal oversight, requires frequent contact with internal and external customers and is critical to the success of the business.

Essential Job Functions


* Responsible for organizing, communicating and evaluating team objectives for clinical studies


* Participates in study design and study preparation activities


* Development of clinical trial documentation including clinical trial protocol development, case report form (CRF) development, IRB/Ethics submissions


* Participates or leads the process to evaluate and select potential investigators and sites


* Participates or leads the process to evaluate and select potential vendors as applicable


* Conducts or oversees site visits as required (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct


* Develops site training tools, interprets clinical data, manages investigational sites, develops tracking tools and performs other clinical activities as needed during clinical study conduct


* Leads clinical study teams focused on conduc...