J&J Family of Companies
Clinical Research Lead
J&J Family of Companies, Little Rock, Arkansas, United States, 72208
J&J Family of Companies - Clinical Research Lead - Little Rock, Arkansas
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.Cerenovus is recruiting for a Clinical Research Leader based in the United States. Primary location for this position is Irvine, California. Local candidate working 2-3 days/week in-office preferred. Remote may be considered.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.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.Generally manage work with limited supervision, dependent on project complexity.Management of a limited number of direct reports.Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with ICH-GCP, applicable legislation and Company Standard Operating Procedures.Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal supervision.Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.Oversee the development and execution of Investigator agreements and trial payments.Responsible for clinical data review to prepare data for statistical analyses and publications.Responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments.Responsible for communicating business-related issues or opportunities to the next management level.Track and manage assigned project budgets to ensure adherence to business plans.Support clinical scientific discussions with regulatory agencies to drive support of the clinical and regulatory strategy.Develop a strong understanding of the pipeline, product portfolio and business needs.Management/oversight of ordering, tracking, and accountability of investigational products and trial materials.May serve as the primary contact for clinical trial sites.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 and evidence dissemination strategies within the assigned projects.May serve as the clinical representative on a New Product Development team.May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging.Perform other duties assigned as needed.QualificationsEducationMinimum of a Bachelor’s Degree required (preferably in Life Science, Physical Science, Nursing, or Biological Science).Experience, Skills and Competencies:Required:BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience.Previous experience in clinical research or equivalent.Experience working well with cross-functional teams.Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations.Proven track record in delivering clinical projects within clinical/surgical research setting, on time, within budget and in compliance with SOPs and regulations.Strong presentation and technical writing skills.Strong written and oral communication skills.Preferred:Medical device experience highly preferred.Experience managing projects.Clinical/medical background a plus.This job posting is anticipated to close on 7/26/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
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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.Cerenovus is recruiting for a Clinical Research Leader based in the United States. Primary location for this position is Irvine, California. Local candidate working 2-3 days/week in-office preferred. Remote may be considered.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.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.Generally manage work with limited supervision, dependent on project complexity.Management of a limited number of direct reports.Oversight/execution of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with ICH-GCP, applicable legislation and Company Standard Operating Procedures.Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal supervision.Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.Oversee the development and execution of Investigator agreements and trial payments.Responsible for clinical data review to prepare data for statistical analyses and publications.Responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments.Responsible for communicating business-related issues or opportunities to the next management level.Track and manage assigned project budgets to ensure adherence to business plans.Support clinical scientific discussions with regulatory agencies to drive support of the clinical and regulatory strategy.Develop a strong understanding of the pipeline, product portfolio and business needs.Management/oversight of ordering, tracking, and accountability of investigational products and trial materials.May serve as the primary contact for clinical trial sites.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 and evidence dissemination strategies within the assigned projects.May serve as the clinical representative on a New Product Development team.May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging.Perform other duties assigned as needed.QualificationsEducationMinimum of a Bachelor’s Degree required (preferably in Life Science, Physical Science, Nursing, or Biological Science).Experience, Skills and Competencies:Required:BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience.Previous experience in clinical research or equivalent.Experience working well with cross-functional teams.Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations.Proven track record in delivering clinical projects within clinical/surgical research setting, on time, within budget and in compliance with SOPs and regulations.Strong presentation and technical writing skills.Strong written and oral communication skills.Preferred:Medical device experience highly preferred.Experience managing projects.Clinical/medical background a plus.This job posting is anticipated to close on 7/26/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
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