Johnson & Johnson MedTech
Clinical Research Leader - JJMT Neurovascular
Johnson & Johnson MedTech, Irvine, California, United States, 92713
Clinical Research Leader - JJMT Neurovascular
Johnson & Johnson MedTech is seeking a
Clinical Research Leader - JJMT Neurovascular
in Irvine, California with a hybrid work schedule (3 days on-site). At Johnson & Johnson, we believe health is everything. Learn more at https://www.jnj.com/.
Job Description
The 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. This role involves planning, executing, and contributing to the delivery of company-sponsored clinical trials in the Neurovascular area, ensuring compliance with timelines, regulatory requirements, and SOPs.
Key Responsibilities
Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company-sponsored clinical trials, ensuring alignment with timelines and study milestones for JNJ MedTech Neurovascular.
Oversee feasibility, selection, setup, conduct, and closure of a clinical trial across allocated countries in accordance with ICH-GCP, applicable legislation, and Company SOPs.
May serve as the primary contact for clinical trial sites (e.g., site management).
Develop clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).
Ensure applicable trial registration (e.g., ClinicalTrials.gov) from study initiation through posting of results and support publications as needed.
Manage/oversee ordering, tracking, and accountability of investigational devices and trial materials.
Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel; coordinate with Clinical Research Associates (CRAs).
Oversee and support the development and execution of Investigator agreements and trial payments.
Conduct clinical data review to prepare data for statistical analyses and publications.
May perform monitoring activities (e.g., site qualification visits, site initiation visits, interim monitoring visits, close-out visits) as needed.
Contribute to the development and delivery of global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), collaborating with Clinical R&D partners and cross-functional teams (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D).
Provide on-site procedural protocol compliance and data collection support to clinical trial sites as needed.
Contribute to critical literature assessment, interpretation, and dissemination of evidence generated.
Deliver assigned clinical projects on time, within budget, and in compliance with regulations and SOPs; manage project budgets and support regulatory discussions.
Support development of PMCF Plans and PMCF Evaluation Reports within defined timelines and coordinate cross-functional reviews of related documents.
Assist with safety-related activities, including safety reporting, safety management planning, and coordination with cross-functional teams to ensure compliance and timely reporting of adverse events.
Mentor resources assigned to designated clinical studies to provide quality deliverables and maintain efficiency.
Qualifications Education
Minimum of a Bachelor’s Degree, preferably in Life Science, Physical Science, Nursing, or Biological Science.
Experience
BS with at least 6 years, MS with at least 5 years, or PhD with at least 3 years of relevant experience preferred; previous experience in clinical research or equivalent is required.
Experience working well with cross-functional teams is required.
Relevant industry certifications preferred (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
Clinical/medical background is a plus; medical device experience is highly preferred.
Required Knowledge, Skills, Abilities, Certifications/Licenses
Strong understanding of clinical research science and processes, product development, and global clinical trial regulations.
Ability to provide scientifically strategic input across New Product Development and Life-Cycle Management projects.
Proven track record delivering clinical projects on time, within budget, and compliant with SOPs and regulations.
Strong presentation and technical writing skills; excellent written and oral English communication.
Advanced project management skills and the ability to handle multiple projects with limited supervision.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. If you are an individual with a disability and would like to request an accommodation, please email ra-employeehealthsup@its.jnj.com.
Compensation and Benefits
The anticipated base pay range for this position is $105,000 - $169,000. The Company maintains competitive, performance-based compensation programs. This position is eligible for an annual performance bonus, with details available at the Careers site. Benefits include medical, dental, vision, life insurance, disability coverage, retirement plans, and paid time off as described by company policy.
Note All other postings and references shown in the original description may be removed to focus on the role and requirements for this position.
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Johnson & Johnson MedTech is seeking a
Clinical Research Leader - JJMT Neurovascular
in Irvine, California with a hybrid work schedule (3 days on-site). At Johnson & Johnson, we believe health is everything. Learn more at https://www.jnj.com/.
Job Description
The 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. This role involves planning, executing, and contributing to the delivery of company-sponsored clinical trials in the Neurovascular area, ensuring compliance with timelines, regulatory requirements, and SOPs.
Key Responsibilities
Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company-sponsored clinical trials, ensuring alignment with timelines and study milestones for JNJ MedTech Neurovascular.
Oversee feasibility, selection, setup, conduct, and closure of a clinical trial across allocated countries in accordance with ICH-GCP, applicable legislation, and Company SOPs.
May serve as the primary contact for clinical trial sites (e.g., site management).
Develop clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).
Ensure applicable trial registration (e.g., ClinicalTrials.gov) from study initiation through posting of results and support publications as needed.
Manage/oversee ordering, tracking, and accountability of investigational devices and trial materials.
Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel; coordinate with Clinical Research Associates (CRAs).
Oversee and support the development and execution of Investigator agreements and trial payments.
Conduct clinical data review to prepare data for statistical analyses and publications.
May perform monitoring activities (e.g., site qualification visits, site initiation visits, interim monitoring visits, close-out visits) as needed.
Contribute to the development and delivery of global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), collaborating with Clinical R&D partners and cross-functional teams (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D).
Provide on-site procedural protocol compliance and data collection support to clinical trial sites as needed.
Contribute to critical literature assessment, interpretation, and dissemination of evidence generated.
Deliver assigned clinical projects on time, within budget, and in compliance with regulations and SOPs; manage project budgets and support regulatory discussions.
Support development of PMCF Plans and PMCF Evaluation Reports within defined timelines and coordinate cross-functional reviews of related documents.
Assist with safety-related activities, including safety reporting, safety management planning, and coordination with cross-functional teams to ensure compliance and timely reporting of adverse events.
Mentor resources assigned to designated clinical studies to provide quality deliverables and maintain efficiency.
Qualifications Education
Minimum of a Bachelor’s Degree, preferably in Life Science, Physical Science, Nursing, or Biological Science.
Experience
BS with at least 6 years, MS with at least 5 years, or PhD with at least 3 years of relevant experience preferred; previous experience in clinical research or equivalent is required.
Experience working well with cross-functional teams is required.
Relevant industry certifications preferred (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
Clinical/medical background is a plus; medical device experience is highly preferred.
Required Knowledge, Skills, Abilities, Certifications/Licenses
Strong understanding of clinical research science and processes, product development, and global clinical trial regulations.
Ability to provide scientifically strategic input across New Product Development and Life-Cycle Management projects.
Proven track record delivering clinical projects on time, within budget, and compliant with SOPs and regulations.
Strong presentation and technical writing skills; excellent written and oral English communication.
Advanced project management skills and the ability to handle multiple projects with limited supervision.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. If you are an individual with a disability and would like to request an accommodation, please email ra-employeehealthsup@its.jnj.com.
Compensation and Benefits
The anticipated base pay range for this position is $105,000 - $169,000. The Company maintains competitive, performance-based compensation programs. This position is eligible for an annual performance bonus, with details available at the Careers site. Benefits include medical, dental, vision, life insurance, disability coverage, retirement plans, and paid time off as described by company policy.
Note All other postings and references shown in the original description may be removed to focus on the role and requirements for this position.
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