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. Learn more at https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

Johnson & Johnson MedTech - Electrophysiology division is currently seeking to fill two Clinical Research Leader positions. These role's preferred location is in Irvine, California however we are open to remote candidates within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

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/.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

This role will be responsible for leading and supporting clinical trials while encouraging strong positive relationships with co-workers across the organization.

Key Responsibilities:

• Serve as a Clinical Research Lead to implement and run company sponsored clinical trials, ensuring compliance with timelines and study milestones, for JJMT Electrophysiology.

• Oversight/execution of feasibility, selection, set up, conduct and closure of the trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.

• Serves as the main 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) with minimal direction.

• Ensure trial registration from study initiation through posting of results and support publications as needed; (e.g. on www.clinicaltrials.gov)

• Management/oversight of ordering, tracking, and accountability of investigational products and trial materials.

• Communicate and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.

• Lead all aspects of development and execution of Investigator agreements and trial payments.

• Leads clinical data review to prepare data for statistical analyses and publications.

• If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.

• If applicable, as part of a clinical study, may provide on-site procedural protocol compliance and data collection support to the center.

• Contribute to the assessment of the literature and to the interpretations and disseminations of all evidence generated.

• Responsible for clinical projects, through partnership with the study core team leading to delivery of clinical project commitments.

• Responsible for communicating business related issues or opportunities to next management level. Function as a trusted resource of accurate, up-to-date project knowledge as requested by crucial team member.

• Supervise and run 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.

• Serve as the clinical representative on the Product Development team

• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures

• Should develop a strong understanding of the pipeline, product portfolio and business needs

• Generally runs work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires minimal guidance for complex situations

• Responsible for communicating business related issues or opportunities to next management level

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable

• For those who supervise or lead staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• May perform other duties assigned as needed

Qualifications:

• Minimum of a bachelor’s degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 6 years clinical research experience is required

Or

• Master’s degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required

Or

• PhD in Life Science, Physical Science, Nursing, or Biological Science or other 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.

• Up to 20% travel is required.

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 interview process that is inclusive of our applicants’ needs. 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.

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