Clinical Research Leader - JJMT Electrophysiology

Clinical Research Leader - JJMT Electrophysiology

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 Med Tech, 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.

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Location: Irvine, California, United States (remote within the United States accepted)

Job Function: Discovery & Pre‑Clinical/Clinical Development

Job Sub‑Function: Clinical Development & Research – Non‑MD

Job Category: Scientific/Technology

• Serve 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.
• Oversee feasibility, selection, set up, conduct and closure of clinical trials within allocated countries, in accordance with ICH‑GCP, applicable legislation and Company SOPs.
• Act as primary contact for clinical trial sites (site management) and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
• Develop clinical trial documents such as study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, and annual reports.
• Ensure trial registration (e.g., clinical trials.gov) from study initiation through posting of results and support publications as needed.
• Manage ordering, tracking, and accountability of investigative devices and trial materials.
• Oversee Clinical Research Associates (CRAs) and support development and execution of investigator agreements and trial payments.
• Prepare clinical data for statistical analyses and publications.
• Perform monitoring activities including site qualification, initiation, interim monitoring, and close‑out visits as needed.
• Contribute to global evidence generation and dissemination strategies in collaboration with cross‑functional partners.
• Provide on‑site procedural protocol compliance and data collection support to trial sites.
• Assist with the development of Post‑Market Clinical Follow‑Up (PMCF) Plans and PMCF Evaluation Reports within defined timelines.
• Review promotional materials to ensure fair balance, accuracy, and appropriate messaging.
• Mentor resources assigned to clinical studies for quality deliverables and efficiency.
• Act as Clinical Safety Coordinator and perform other duties as assigned.
• Communicate business‑related issues or opportunities to next management level.
• Ensure compliance with all federal, state, local, and company regulations, policies, and procedures.
• Develop a strong understanding of the pipeline, product portfolio, and business needs.
• Manage work with limited supervision, exercising independent decision‑making when appropriate.
• Follow all Company guidelines related to Health, Safety and Environmental practices.
• Perform other duties as needed.

• Master’s degree in Life Science, Physical Science, Nursing, Biological Science, or related field with at least 5 years clinical research experience; or PhD with at least 3 years experience; or Bachelor’s degree with at least 6 years experience.
• Experience with project/team leadership.
• Relevant industry certifications preferred (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
• Medical device experience highly preferred.
• CRO experience and site management/monitoring assets.
• Experience delivering presentations and writing clinical reports.
• Up to 20% travel required.
• Preferred: knowledge of cardiology and electrophysiology science.

Base pay range: $ – $

• Vacation – 120 hours per calendar year.
• Sick time – 40 hours per calendar year.
• Holiday pay (including floating holidays) – 13 days per calendar year.
• Work, personal and family time – up to 40 hours per calendar year.
• Parental leave – 480 hours within one year of birth/adoption/foster care.
• Bereavement leave – 240 hours for an immediate family member; 40 hours for an extended family member per…