【Shockwave】Associate Director, Clinical Affairs

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:
People Leader

All Job Posting Locations:
Chuo-ku, Tokyo, Japan, Santa Clara, California, United States of America

Job Description:

Position Overview

The Principal Clinical Research Manager will be responsible for the support and oversight of one or more clinical programs conducted in Japan.

The individual will be accountable for multiple clinical studies, including clinical study planning, project management activities, oversight of clinical research organizations (CROs) and other vendors, ensuring alignment between Shockwave Medical Inc.’s (SWMI) Clinical Affairs business unit and local SWMI Japanese teams, and for conducting domestic and global clinical studies in compliance with regulatory standards and in alignment with SWMI business needs.

This work is accomplished with minimal oversight, requires frequent contact with internal teams in the US and Japan, with Japanese physician customers/sites and regulatory authorities, and is critical to the success of the business.

Essential Job Functions


* Responsible for the day-to-day management of domestic and global clinical studies conducted in Japan for pre- and post-market studies. 


*


* Develop clinical trial documentation, with the US Clinical Affairs team, including clinical trial protocol development, case report form (CRF) development, Investigator’s Brochure, IRB or ethics submissions and site contracts.


* Develop site-training tools and tracking tools, interpret clinical data, and manage investigational sites.


* Manage clinical trial vendors (e.g., CRO, imaging core lab(s), IVRS, central labs, IRB).


* Support the selection of CRO study staff, coordinating CRO staff training and ensuring documentation of training completion.


* Work closely to meet corporate objectives with Japanese peers including Regulatory, Project Management, and Medical Affairs teams. 


* Support and manage Japanese physician and site relationships involved in SWMI clinical studies.


* Participate in Investigator meetings with National PIs and study Investigators, as needed.


* Participate in Japanese regulatory meetings associated with clinical studies.


* Coordinate and manage investigational products including accountability and reconciliation.


* Manage training of investigators, site staff, and SWMI clinical staff.


* ...