Clinical Research Leader

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: Scientific/Technology All Job Posting Locations: Irvine, California, United States of America Job Description: Johnson & Johnson MedTech, Neurovascular, is recruiting a Clinical Research Leader, Neurovascular, to join our team. This position is located in Irvine, CA.   At management discretion, the position may be performed remotely. 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 Neurovascular? Ready to join a team that’s reimagining how we heal? Our Neurovascular team develops leading solutions for hemorrhagic and acute ischemic stroke. You will join a proud heritage of continually elevating standards of care for neurovascular stroke patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech.   JOB SUMMARY Under minimal supervision, this Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.    DUTIES & RESPONSIBILITIES In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Serves as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for JJMT Neurovascular Clinical; Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;  May serve as the primary contact for clinical trial sites (e.g. site management); Develops clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports); Ensures applicable trial registration (e.g. on www.clinicaltrials.gov ) from study initiation through posting of results and support publications as needed; Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials; Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel; Interfaces, collaborates and oversees Clinical Research Associates (CRAs); Oversees and supports the development and execution of Investigator agreements and trial payments; Is responsible for clinical data review to prepare data for statistical analyses and publications; May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need; May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), contributing to cross-functional alignment; May provide on-site procedural protocol compliance and data collection support to the clinical trial sites; Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated; Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs); Supports planning, track and manage assigned project budgets to ensure adherence to business plans;  Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy; May serve as the clinical representative on a New Product Development team; May assist with the development of  Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals; May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review