Johnson & Johnson MedTech
Clinical Research Manager
Johnson & Johnson MedTech, Irvine, California, United States, 92713
Clinical Research Manager
Join to apply for the
Clinical Research Manager
role at
Johnson & Johnson MedTech
located in Irvine, California, United States of America. This role supports our Electrophysiology business and works on a Flex/Hybrid schedule with 3 days per week onsite in our Irvine, CA office.
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, 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, profoundly impacting health for humanity.
Purpose The Clinical Research Manager will be responsible for clinical trial management within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
Responsibilities
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 Standard Operating Procedures.
Manage ordering, tracking, and accountability of investigational products and trial materials.
Ensure applicable trial registration (e.g., www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed.
Serve as the team’s interface and collaborate with key opinion leaders, investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations, and company personnel.
Perform 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 based on study need.
In EMEA, handle Regulatory Affairs related tasks associated with clinical trials and evidence generation.
Contribute to the development and delivery of appropriate Global EGS/EDS to support New Product Development and Life‑Cycle Management, ensuring cross‑functional alignment.
Lead study design to develop appropriate clinical trials to meet evidence needs.
Provide onsite procedural protocol compliance and data collection support to clinical trial sites as needed.
Interpret and disseminate evidence generated, including Clinical Study Reports, Abstracts, Manuscripts, Clinical Evaluation Reports, etc.
Deliver assigned clinical projects on time, within budget and in compliance with regulations and SOPs.
Plan, track, and manage assigned project budgets to ensure adherence to business plans.
Participate in clinical scientific discussions with regulatory agencies and notified bodies to support clinical and regulatory strategy.
Serve as the clinical representative on a New Product Development team.
Develop Post‑Market Clinical Follow‑up (PMCF) Plans and Reports.
Review promotional materials to ensure fair balance, accuracy in clinical claims, and messaging.
Ensure subordinates follow all Company guidelines related to Health, Safety and Environmental practices.
Manage and mentor resources assigned to clinical trials to provide quality deliverables while maintaining efficiency.
Provide performance feedback to direct reports (if applicable) and coach their development.
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 independently, solving problems arising during clinical trial execution and seeking guidance for more complex issues when needed.
Perform other duties as assigned.
Requirements
Minimum of a Bachelor’s Degree in Life Science, Physical Science, Nursing, Biological Science, or related scientific degree.
Minimum of 8 years related scientific/technical experience, including a leadership/management role within Clinical Research.
Significant previous experience in clinical project leadership across multiple studies/programs.
Experience working well with cross‑functional teams.
1‑2 years people‑management related experience.
Medical device experience is highly preferred.
Experience with budget planning, tracking and control is preferred.
Relevant industry certifications (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR) are preferred.
Clinical/medical background is preferred.
Functional And Technical Competencies
Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations.
Ability to provide scientifically strategic and clinical research input across New Product Development and Life‑Cycle Management projects, including complex and/or transformational projects; proven track record in delivering clinical projects on time, within budget and in compliance with SOPs and regulations.
Strong presentation and technical writing skills.
Strong written and oral English communication skills.
Comprehensive understanding of clinical trial regulations across multiple regions.
Leadership Competencies
Connect – Develop strong collaborative relationships with key internal and external stakeholders to ensure development and timely delivery of innovative EGS/EDS. Create strong and productive partnerships with resource providers and vendors.
Shape – Make recommendations for and actively participate and lead in departmental process improvement activities. Through efficient use of resources, shape the way clinical trial management is conducted and resources are utilized.
Lead – Continually develop expertise to provide strategic and scientific clinical research capability. Ensure appropriate escalation of compliance issues.
Deliver – Ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance to SOPs and regulations. Ensure all sponsored studies have appropriately trained clinical trial leaders/specialists assigned.
Equal Opportunity Employer 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 under 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.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants may contact
https://www.jnj.com/contact-us/careers
and internal employees contact AskGS to be directed to your accommodation resource.
Pay The anticipated base pay range for this position is: $117,000.00 – $201,250.00.
Benefits Subject to the terms of the Company’s policies and date of hire, employees are eligible for the following time‑off benefits:
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours; for employees who reside in the State of Washington – 56 hours
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 the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52‑week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time‑Off – 80 hours per calendar year
For additional general information on Company benefits, please go to:
https://www.careers.jnj.com/employee-benefits .
#J-18808-Ljbffr
Clinical Research Manager
role at
Johnson & Johnson MedTech
located in Irvine, California, United States of America. This role supports our Electrophysiology business and works on a Flex/Hybrid schedule with 3 days per week onsite in our Irvine, CA office.
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, 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, profoundly impacting health for humanity.
Purpose The Clinical Research Manager will be responsible for clinical trial management within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
Responsibilities
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 Standard Operating Procedures.
Manage ordering, tracking, and accountability of investigational products and trial materials.
Ensure applicable trial registration (e.g., www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed.
Serve as the team’s interface and collaborate with key opinion leaders, investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations, and company personnel.
Perform 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 based on study need.
In EMEA, handle Regulatory Affairs related tasks associated with clinical trials and evidence generation.
Contribute to the development and delivery of appropriate Global EGS/EDS to support New Product Development and Life‑Cycle Management, ensuring cross‑functional alignment.
Lead study design to develop appropriate clinical trials to meet evidence needs.
Provide onsite procedural protocol compliance and data collection support to clinical trial sites as needed.
Interpret and disseminate evidence generated, including Clinical Study Reports, Abstracts, Manuscripts, Clinical Evaluation Reports, etc.
Deliver assigned clinical projects on time, within budget and in compliance with regulations and SOPs.
Plan, track, and manage assigned project budgets to ensure adherence to business plans.
Participate in clinical scientific discussions with regulatory agencies and notified bodies to support clinical and regulatory strategy.
Serve as the clinical representative on a New Product Development team.
Develop Post‑Market Clinical Follow‑up (PMCF) Plans and Reports.
Review promotional materials to ensure fair balance, accuracy in clinical claims, and messaging.
Ensure subordinates follow all Company guidelines related to Health, Safety and Environmental practices.
Manage and mentor resources assigned to clinical trials to provide quality deliverables while maintaining efficiency.
Provide performance feedback to direct reports (if applicable) and coach their development.
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 independently, solving problems arising during clinical trial execution and seeking guidance for more complex issues when needed.
Perform other duties as assigned.
Requirements
Minimum of a Bachelor’s Degree in Life Science, Physical Science, Nursing, Biological Science, or related scientific degree.
Minimum of 8 years related scientific/technical experience, including a leadership/management role within Clinical Research.
Significant previous experience in clinical project leadership across multiple studies/programs.
Experience working well with cross‑functional teams.
1‑2 years people‑management related experience.
Medical device experience is highly preferred.
Experience with budget planning, tracking and control is preferred.
Relevant industry certifications (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR) are preferred.
Clinical/medical background is preferred.
Functional And Technical Competencies
Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations.
Ability to provide scientifically strategic and clinical research input across New Product Development and Life‑Cycle Management projects, including complex and/or transformational projects; proven track record in delivering clinical projects on time, within budget and in compliance with SOPs and regulations.
Strong presentation and technical writing skills.
Strong written and oral English communication skills.
Comprehensive understanding of clinical trial regulations across multiple regions.
Leadership Competencies
Connect – Develop strong collaborative relationships with key internal and external stakeholders to ensure development and timely delivery of innovative EGS/EDS. Create strong and productive partnerships with resource providers and vendors.
Shape – Make recommendations for and actively participate and lead in departmental process improvement activities. Through efficient use of resources, shape the way clinical trial management is conducted and resources are utilized.
Lead – Continually develop expertise to provide strategic and scientific clinical research capability. Ensure appropriate escalation of compliance issues.
Deliver – Ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance to SOPs and regulations. Ensure all sponsored studies have appropriately trained clinical trial leaders/specialists assigned.
Equal Opportunity Employer 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 under 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.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants may contact
https://www.jnj.com/contact-us/careers
and internal employees contact AskGS to be directed to your accommodation resource.
Pay The anticipated base pay range for this position is: $117,000.00 – $201,250.00.
Benefits Subject to the terms of the Company’s policies and date of hire, employees are eligible for the following time‑off benefits:
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours; for employees who reside in the State of Washington – 56 hours
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 the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52‑week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time‑Off – 80 hours per calendar year
For additional general information on Company benefits, please go to:
https://www.careers.jnj.com/employee-benefits .
#J-18808-Ljbffr