Clinical Science & External Research Manager

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research – Non-MD Job Category: People Leader All Job Posting Locations: Irvine, California, United States of America Job Description: Johnson & Johnson MedTech Electrophysiology is recruiting for a Clinical Science & External Research Manager to support the Electrophysiology (EP) business unit based in Irvine, CA. 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. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at  https://www.jnj.com/medtech . The Clinical Science & External Research Manager will drive end-to-end evidence generation strategies (EGS). In collaboration with cross-functional teams and research investigators, the CSER manager will generate clinically relevant evidence for the company's innovative pipeline that impact patient lives. OVERALL RESPONSIBILITIES: Handles assigned study programs (investigator Initiated, registries, real-world evidence, collaborative studies) Manages the external research program activities including the investigator sponsored trial program ensuring high adherence to SOPs, ICH-GCPs. Responsible for new study proposal review, ensures timely decision making and execution of approved studies including while working with external stakeholders Utilizes program data and metrics to conduct regular reviews of the program and provides updates to team leadership Supports evidence generation and dissemination strategy through external research program, including alignment of publication plan and identifies gaps Drives publication development with investigators and internally cross functionally with scientific affairs. Provides critical scientific input to publications Handles assigned studies (investigator Initiated, registries, real-world evidence or company sponsored post-market /premarket collaborative studies) Contributes to protocol development of assigned studies Provides input to company and investigator sponsored studies’ protocols as needed POSITION DUTIES & RESPONSIBILITIES:   Functional and Technical Competencies : Strong