myGwork - LGBTQ+ Business Community
Clinical Research Leader - JJMT Neurovascular
myGwork - LGBTQ+ Business Community, Irvine, California, United States, 92713
Clinical Research Leader - JJMT Neurovascular
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Clinical Research Leader - JJMT Neurovascular
role at
myGwork - LGBTQ+ Business Community .
Posted 2 days ago. Location: Irvine, California, United States of America. Hybrid work schedule: 3 days on-site per week.
About Johnson & Johnson Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community, believes 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.
Job Description Johnson & Johnson MedTech – Neurovascular Division is seeking a Clinical Research Leader. The position is located in Irvine, California and has a hybrid work schedule of 3 days a week on site.
Key Responsibilities
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, for JNJ MedTech Neurovascular.
Oversee feasibility, site selection, activation, conduct, and closure of clinical trials within the allocated countries, in accordance with ICH‑GCP, applicable legislation, and Company Standard Operating Procedures.
Serve as the primary contact for clinical trial sites.
Develop clinical trial documents such as study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, and annual reports.
Ensure applicable trial registration (e.g., on clinicaltrials.gov) from study initiation through posting of results and support publications as needed.
Manage ordering, tracking, and accountability of investigational devices and trial materials.
Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
Interface, collaborate, and oversee 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.
Perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits, or close‑out visits as required.
Contribute to development and delivery of global evidence generation and dissemination strategies in collaboration with Clinical R&D partners and cross‑functional partners.
Provide on‑site procedural protocol compliance and data collection support to the clinical trial sites.
Contribute to the critical assessment of literature, interpretation, and dissemination of all evidence generated.
Lead clinical project delivery through effective partnership with the study core team, ensuring on‑time, on‑budget, and compliant outcomes.
Plan, track, and manage assigned project budgets to ensure adherence to business plans.
Support clinical scientific discussions with regulatory agencies and notified bodies.
Assist in development of Post‑Market Clinical Follow‑up Plans and evaluation reports within defined timelines.
Maintain an overview to assure study commitments are timely and properly met.
Conduct review of promotional materials to ensure fair balance, accuracy in clinical claims, and messaging.
Manage and mentor resources assigned to designated clinical studies.
Act as a reliable, trusted resource of accurate, up‑to‑date project knowledge as requested by stakeholders.
Ensure personal and company 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, making independent decisions for complex situations while requiring minimal guidance for simpler cases.
Communicate business‑related issues or opportunities to the next management level.
Follow all Company guidelines related to Health, Safety, and Environmental practices.
May act as Clinical Safety Coordinator responsible for safety coordination, strategic planning, and creation of safety reports and boards.
Qualifications Education
Minimum of a Bachelor’s Degree in Life Science, Physical Science, Nursing, or Biological Science.
Experience
BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred.
Previous experience in clinical research or equivalent required.
Experience working well with cross‑functional teams required.
Relevant industry certifications preferred (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV, etc.).
Clinical/medical background is a plus.
Medical device experience highly preferred.
Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations
Deep understanding of clinical research science and processes along with product development, clinical trends, and global clinical trial regulations.
Ability to provide scientifically strategic and evidence‑based input across New Product Development and Life‑Cycle Management.
Proven track record of delivering clinical projects on time, within budget, and in compliance with SOPs and regulations.
Strong presentation and technical writing skills.
Excellent written and oral English communication skills.
Professional and ethical conduct.
Advanced project management skills with ability to handle multiple projects.
EEO Statement 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 the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
Salary $105,000 – $169,000
Pay Transparency The Company maintains highly competitive, performance‑based compensation programs. This position is eligible for an annual performance bonus in accordance with the company’s applicable plans and programs. Employees may be eligible to participate in the following company‑sponsored benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability, and group legal insurance. Employees may also participate in the company’s 401(k) retirement plan and long‑term incentive program. Eligible employees receive the following time‑off benefits: Vacation (up to 120 hours per calendar year), sick time (up to 40 hours per calendar year), holiday pay, floating holidays, and work‑family time. Additional information can be found at
https://www.careers.jnj.com/employee-benefits .
Location and Work Schedule Irvine, CA. Hybrid work schedule: 3 days on site per week.
Seniority Level Mid‑Senior level.
Employment Type Full‑time.
Job Function Research, Analyst, and Information Technology.
Industries Hospitals and Health Care.
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Clinical Research Leader - JJMT Neurovascular
role at
myGwork - LGBTQ+ Business Community .
Posted 2 days ago. Location: Irvine, California, United States of America. Hybrid work schedule: 3 days on-site per week.
About Johnson & Johnson Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community, believes 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.
Job Description Johnson & Johnson MedTech – Neurovascular Division is seeking a Clinical Research Leader. The position is located in Irvine, California and has a hybrid work schedule of 3 days a week on site.
Key Responsibilities
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, for JNJ MedTech Neurovascular.
Oversee feasibility, site selection, activation, conduct, and closure of clinical trials within the allocated countries, in accordance with ICH‑GCP, applicable legislation, and Company Standard Operating Procedures.
Serve as the primary contact for clinical trial sites.
Develop clinical trial documents such as study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, and annual reports.
Ensure applicable trial registration (e.g., on clinicaltrials.gov) from study initiation through posting of results and support publications as needed.
Manage ordering, tracking, and accountability of investigational devices and trial materials.
Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
Interface, collaborate, and oversee 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.
Perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits, or close‑out visits as required.
Contribute to development and delivery of global evidence generation and dissemination strategies in collaboration with Clinical R&D partners and cross‑functional partners.
Provide on‑site procedural protocol compliance and data collection support to the clinical trial sites.
Contribute to the critical assessment of literature, interpretation, and dissemination of all evidence generated.
Lead clinical project delivery through effective partnership with the study core team, ensuring on‑time, on‑budget, and compliant outcomes.
Plan, track, and manage assigned project budgets to ensure adherence to business plans.
Support clinical scientific discussions with regulatory agencies and notified bodies.
Assist in development of Post‑Market Clinical Follow‑up Plans and evaluation reports within defined timelines.
Maintain an overview to assure study commitments are timely and properly met.
Conduct review of promotional materials to ensure fair balance, accuracy in clinical claims, and messaging.
Manage and mentor resources assigned to designated clinical studies.
Act as a reliable, trusted resource of accurate, up‑to‑date project knowledge as requested by stakeholders.
Ensure personal and company 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, making independent decisions for complex situations while requiring minimal guidance for simpler cases.
Communicate business‑related issues or opportunities to the next management level.
Follow all Company guidelines related to Health, Safety, and Environmental practices.
May act as Clinical Safety Coordinator responsible for safety coordination, strategic planning, and creation of safety reports and boards.
Qualifications Education
Minimum of a Bachelor’s Degree in Life Science, Physical Science, Nursing, or Biological Science.
Experience
BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred.
Previous experience in clinical research or equivalent required.
Experience working well with cross‑functional teams required.
Relevant industry certifications preferred (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV, etc.).
Clinical/medical background is a plus.
Medical device experience highly preferred.
Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations
Deep understanding of clinical research science and processes along with product development, clinical trends, and global clinical trial regulations.
Ability to provide scientifically strategic and evidence‑based input across New Product Development and Life‑Cycle Management.
Proven track record of delivering clinical projects on time, within budget, and in compliance with SOPs and regulations.
Strong presentation and technical writing skills.
Excellent written and oral English communication skills.
Professional and ethical conduct.
Advanced project management skills with ability to handle multiple projects.
EEO Statement 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 the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
Salary $105,000 – $169,000
Pay Transparency The Company maintains highly competitive, performance‑based compensation programs. This position is eligible for an annual performance bonus in accordance with the company’s applicable plans and programs. Employees may be eligible to participate in the following company‑sponsored benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability, and group legal insurance. Employees may also participate in the company’s 401(k) retirement plan and long‑term incentive program. Eligible employees receive the following time‑off benefits: Vacation (up to 120 hours per calendar year), sick time (up to 40 hours per calendar year), holiday pay, floating holidays, and work‑family time. Additional information can be found at
https://www.careers.jnj.com/employee-benefits .
Location and Work Schedule Irvine, CA. Hybrid work schedule: 3 days on site per week.
Seniority Level Mid‑Senior level.
Employment Type Full‑time.
Job Function Research, Analyst, and Information Technology.
Industries Hospitals and Health Care.
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