Clinical Research Leader

Johnson Johnson

Irvine (CA)

Hybrid

USD 110,000 - 150,000

Full time

5 days ago
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Job summary

Johnson & Johnson MedTech, Neurovascular, is recruiting a Clinical Research Leader, Neurovascular, to join our team in Irvine, CA. The role may be performed remotely at management discretion, with responsibilities across multiple clinical trials in the Clinical R&D group.

Under minimal supervision, you will lead company-sponsored trials, ensure compliance with ICH-GCP and regulatory standards, and collaborate with sites, IRBs, vendors, and internal teams to advance neurovascular stroke research.

Qualifications

  • Experience leading one or more clinical trials in a regulated environment.
  • Strong knowledge of ICH-GCP guidelines and regulatory requirements.
  • Ability to work cross-functionally with R&D, sites, CROs and vendors.

Responsibilities

  • Lead and manage company-sponsored clinical trials in Neurovascular.
  • Ensure trials comply with timelines, milestones, and GCP requirements.
  • Serve as primary site contact and oversee site management activities.
  • Develop trial documents including protocols and informed consent forms.
  • Ensure proper trial registration and publication support as needed.
  • Oversee handling of investigational devices and trial materials.
  • Collaborate with IRBs/ECs, contractors, and internal stakeholders.
  • Support CRA activities and trial readiness across regions.

Skills

Clinical Trials
ICH-GCP
Leadership
Cross-functional
Stakeholder Management

Education

Bachelor's degree in life sciences

Job description

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
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