Clinical Research Leader

Johnson & Johnson MedTech; Irvine (CA); On-site; USD 109,000 - 175,000; Full time

Job summary

Johnson & Johnson MedTech in Irvine, CA is seeking a Clinical Research Leader for the electrophysiology team. This on-site role will lead company-sponsored trials, ensuring timelines and milestones for Biosense Webster in compliance with ICH-GCP and regulatory requirements.

You will collaborate with site personnel, IRBs/ECs, vendors, and internal teams; develop trial documents; support trial registrations; monitor budgets; and contribute to data reviews and publications.

Qualifications

• Minimum bachelor’s degree in Life Science or related field with at least 6 years clinical research experience; or Master’s with at least 5 years; or PhD with at least 3 years.
• Experience with project/team leadership is required.
• Relevant industry certifications are preferred (examples: CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).

Responsibilities

• Serve as a Clinical Research Lead to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for Biosense Webster.
• Oversight/execution of feasibility, selection, set up, conduct and closure of the trial within the allocated countries, in accordance with ICH-GCP and company procedures.
• Develop clinical trial documents (protocols, informed consents, CRFs, monitoring plans, manuals, investigator brochures).
• Ensure trial registration from study initiation through posting of results (ClinicalTrials.gov).
• Management/oversight of ordering, tracking, and accountability of investigational products and trial materials.
• Collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.

Skills

Analytical Reasoning

Clinical Data Management

Clinical Evaluations

Clinical Trial Protocols

Regulatory Affairs Management

Research Documents

Coaching

Consulting

Education

Bachelor's degree Life Science

Master's degree Life Science

PhD Life Science

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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:

Our J&J MedTech Electrophysiology clinical team is currently recruiting for a Clinical Research Leader. This role is located in Irvine, California.

Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

• Serve as a Clinical Research Lead to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for Biosense Webster.
• 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 key team member.
• Supervise 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.
• 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 manages 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 manage a 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 Masters 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.
• 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 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 ([e-mail]) or contact AskGS to be directed to your accommodation resource.

Required Skills:

Analytical Reasoning, Clinical Data Management, Clinical Evaluations, Clinical Trial Protocols, Coaching, Consulting, Data Savvy, Drug Discovery Development, Good Clinical Practice (GCP), Medicines and Device Development and Regulation, Persistence and Tenacity, Regulatory Affairs Management, Research Documents, Resource Management, Safety-Oriented, Scientific Research, Technologically Savvy

Preferred Skills:

Analytical Reasoning, Clinical Data Management, Clinical Evaluations, Clinical Trial Protocols, Coaching, Consulting, Data Savvy, Drug Discovery Development, Good Clinical Practice (GCP), Medicines and Device Development and Regulation, Persistence and Tenacity, Regulatory Affairs Management, Research Documents, Resource Management, Safety-Oriented, Scientific Research, Technologically Savvy

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

Additional Description For Pay Transparency:

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• 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 period10 days
• 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