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:

People Leader

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

Job Description Johnson & Johnson Med Tech, Electrophysiology, is recruiting a **Clinical Research Manager.**This role is based in Irvine, CA on a hybrid work schedule onsite 2-3 days a week.

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

Summary

Under limited supervision, this Clinical Research Manager will provide leadership to Clinical Research Scientists ensuring the successful performance and delivery of project deliverables, on time with high quality. The Clinical Research Manager with be a part of the Clinical Science & External Research (CSER) Team and be responsible for encouraging strong, positive relationships with co-workers across the organization.

Key Duties/Responsibilities

• Oversees the study program, ensures compliance with procedures, monitors studies based on data need, identifies risks with appropriate escalation
• Drives prioritization within the research program based on strategic direction
• Ensures that timelines, risks and publications are tracked, validated and communicated
• Reviews the program dashboard and tracers, provides inputs as needed and synthesizes study level details into summaries
• Manages assigned study level execution for pre-market and post-market collaborative studies, including protocol development, cross functional collaboration for approvals, ensuring compliance for data collection, and data review.
• Represents the program in meetings as needed
• Provides leadership and oversight for scientific aspects of the program– study design review, literature search quality check, study level scientific accuracy in tracker and reports
• May be involved in the management and oversight of device ordering, tracking, and accountability of investigational products and trial materials
• May be involved in the team’s interface and collaboration with key opinion leadersand external researchers
• May liaise with regional partners to ensure global standard processes are shared and applied across the organization
• Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
• Has a strong understanding of the pipeline, product portfolio and strategic business needs
• Manages work independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed
• 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
• Performs other duties assigned as needed

Qualifications

Required Education & Skills/Experience:

• Minimum of a bachelor’s degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 8 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 7 years clinical research experience is required

OR

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

• Previous experience in managing or supervising global clinical trials

• A minimum of 2 years leadership / management role within Clinical Research including 1-2 years of people management experience is required.

• Clinical project leadership across multiple studies/ programs is required.

• Experience working well with cross-functional teams is required.

• Experience with budget planning, tracking and control is required.

• Medical Device experience is required.

• Sound knowledge of ICH-GCP, Clinical trial procedures

Preferred Education & Skills/Experience:

• Relevant industry certifications are preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, …).
• Clinical/medical background is a plus.

Other:

• This position may require up to 35% travel depending on the phase of the program.
• Primary location for this position is Irvine, CA. At management discretion, the position may be performed remotely.

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.

#PULSE #EP

Required Skills:

Preferred Skills:

Clinical Data Management, Clinical Evaluations, Consulting, Developing Others, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Operational Excellence, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Team Management