Clinical Research Manager - JJMT Electrophysiology

Johnson & Johnson•Irvine, CA

37d•Hybrid

About The Position

Johnson & Johnson MedTech, 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,â¯we believe health is everything. Our strength in healthcare innovation empowers us to build aâ¯world where complex diseases are prevented, treated, and cured,â¯where treatments are smarter and less invasive, andâ¯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.

Requirements

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

Nice To Haves

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

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 leaders and 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