Johnson & Johnson
Clinical Research Leader JJMT Electrophysiology
Johnson & Johnson, Irvine, California, United States, 92713
Overview
Johnson & Johnson MedTech - Electrophysiology division is currently seeking to fill two Clinical Research Leader positions. This position is located in Irvine, California and has a hybrid work schedule of 3 days a week on-site. 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. This role will be responsible for leading and supporting clinical trials while encouraging strong positive relationships with co-workers across the organization. Responsibilities
Lead and support one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
Execute and manage company-sponsored clinical trials, ensuring compliance with timelines and study milestones in accordance with applicable laws and Company SOPs.
Oversee/execute feasibility, selection, setup, conduct and closure of a clinical trial within 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., on www.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. Oversee Clinical Research Associates (CRAs).
Oversee and support the development and execution of Investigator agreements and trial payments.
Be responsible for clinical data review to prepare data for statistical analyses and publications.
May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
Contribute to development and delivery of global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), collaborating with Clinical R&D partners and cross-functional partners to align.
Provide on-site procedural protocol compliance and data collection support to clinical trial sites.
Contribute to critical assessment of the literature and interpretation/dissemination of all evidence generated.
Deliver assigned clinical projects through partnership with the study core team, meeting commitments on time and within budget and in compliance with regulations and SOPs.
Support planning, tracking and management of assigned project budgets to ensure adherence to business plans.
Support clinical scientific discussions with regulatory agencies/notified bodies to drive support of the clinical and regulatory strategy.
May serve as the clinical representative on a New Product Development team.
Assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports within defined timelines and coordinate documentation review with cross-functional teams where relevant.
Review promotional materials to ensure fair balance and accuracy in clinical claims and messaging.
Mentor resources assigned to designated clinical studies to provide quality deliverables with optimal efficiency.
May act as Clinical Safety Coordinator (see ANNEX I Clinical Safety Coordinator Duties and Responsibilities).
Communicate business-related issues or opportunities to management and serve as a reliable, trusted resource of up-to-date project knowledge.
Ensure personal and company compliance with all regulations, policies and procedures.
Develop a strong understanding of the pipeline, product portfolio and business needs.
Generally manage work with limited supervision; independent decision-making for simple and some complex situations with minimal guidance for more complex situations.
Adhere to all Health, Safety and Environmental guidelines; ensure resources needed to comply are available and in good condition if applicable.
For supervisors/managers: ensure subordinates follow Health, Safety and Environmental practices and that required resources are available.
Performs other duties as needed.
Qualifications
Minimum of a bachelors degree in Life Science, Physical Science, Nursing, or Biological Science or related field with at least 6 years clinical research experience is required Or Masters degree in Life Science, Physical Science, Nursing, or Biological Science or related field with at least 5 years clinical research experience is required Or PhD in Life Science, Physical Science, Nursing, or Biological Science or related field with at least 3 years clinical research experience is required Experience with project/team leadership is required Relevant industry certifications are preferred (examples may include: CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV) Medical device experience highly preferred CRO experience and site management and clinical site monitoring are assets Experience delivering presentations and writing clinical reports is preferred This position will require on-site work in Irvine, CA, on average up to 2-3 days weekly, as well as attendance at critical on-site meetings as scheduled 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. Johnson and Johnson is committed to providing an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS for accommodation resources. The anticipated base pay range for this position is: $105,000 - $169,050 Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. This position is eligible for an annual performance bonus and other benefits described in the companys employee benefits information. Details available at the company benefits page. #J-18808-Ljbffr
Johnson & Johnson MedTech - Electrophysiology division is currently seeking to fill two Clinical Research Leader positions. This position is located in Irvine, California and has a hybrid work schedule of 3 days a week on-site. 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. This role will be responsible for leading and supporting clinical trials while encouraging strong positive relationships with co-workers across the organization. Responsibilities
Lead and support one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
Execute and manage company-sponsored clinical trials, ensuring compliance with timelines and study milestones in accordance with applicable laws and Company SOPs.
Oversee/execute feasibility, selection, setup, conduct and closure of a clinical trial within 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., on www.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. Oversee Clinical Research Associates (CRAs).
Oversee and support the development and execution of Investigator agreements and trial payments.
Be responsible for clinical data review to prepare data for statistical analyses and publications.
May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
Contribute to development and delivery of global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), collaborating with Clinical R&D partners and cross-functional partners to align.
Provide on-site procedural protocol compliance and data collection support to clinical trial sites.
Contribute to critical assessment of the literature and interpretation/dissemination of all evidence generated.
Deliver assigned clinical projects through partnership with the study core team, meeting commitments on time and within budget and in compliance with regulations and SOPs.
Support planning, tracking and management of assigned project budgets to ensure adherence to business plans.
Support clinical scientific discussions with regulatory agencies/notified bodies to drive support of the clinical and regulatory strategy.
May serve as the clinical representative on a New Product Development team.
Assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports within defined timelines and coordinate documentation review with cross-functional teams where relevant.
Review promotional materials to ensure fair balance and accuracy in clinical claims and messaging.
Mentor resources assigned to designated clinical studies to provide quality deliverables with optimal efficiency.
May act as Clinical Safety Coordinator (see ANNEX I Clinical Safety Coordinator Duties and Responsibilities).
Communicate business-related issues or opportunities to management and serve as a reliable, trusted resource of up-to-date project knowledge.
Ensure personal and company compliance with all regulations, policies and procedures.
Develop a strong understanding of the pipeline, product portfolio and business needs.
Generally manage work with limited supervision; independent decision-making for simple and some complex situations with minimal guidance for more complex situations.
Adhere to all Health, Safety and Environmental guidelines; ensure resources needed to comply are available and in good condition if applicable.
For supervisors/managers: ensure subordinates follow Health, Safety and Environmental practices and that required resources are available.
Performs other duties as needed.
Qualifications
Minimum of a bachelors degree in Life Science, Physical Science, Nursing, or Biological Science or related field with at least 6 years clinical research experience is required Or Masters degree in Life Science, Physical Science, Nursing, or Biological Science or related field with at least 5 years clinical research experience is required Or PhD in Life Science, Physical Science, Nursing, or Biological Science or related field with at least 3 years clinical research experience is required Experience with project/team leadership is required Relevant industry certifications are preferred (examples may include: CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV) Medical device experience highly preferred CRO experience and site management and clinical site monitoring are assets Experience delivering presentations and writing clinical reports is preferred This position will require on-site work in Irvine, CA, on average up to 2-3 days weekly, as well as attendance at critical on-site meetings as scheduled 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. Johnson and Johnson is committed to providing an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS for accommodation resources. The anticipated base pay range for this position is: $105,000 - $169,050 Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. This position is eligible for an annual performance bonus and other benefits described in the companys employee benefits information. Details available at the company benefits page. #J-18808-Ljbffr