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Clinical Research Manager

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Johnson & Johnson

Johnson & Johnson

Clinical Research Manager

Irvine, CA
Full Time
Paid
  • Responsibilities

    Biosense Webster, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Clinical Research Manager to support Irvine, California.  Remote work options may be considered, on a case-by-case basis and if approved by the Company!

    At Biosense Webster, Inc. we have one goal — to ensure those with cardiac arrhythmias can live the lives they want. This means transforming the latest advancements in electrophysiology into a suite of tools that empowers physicians with a range of treatments for the best outcomes.

    Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we’ve been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools. And through onsite training, online courses and our global education centers, we work together to set new standards every day.

    Learn more about Biosense Webster at www.biosensewebster.com and follow us on LinkedIn.

    This Clinical Research Manager will be responsible for clinical trial development and management within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

    KEY RESPONSIBILITIES:

    Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

    • Serves as a Clinical Research Manager within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones for Biosense Webster;
    • Has oversight of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
    • Is responsible for team’s interface and collaboration with key opinion leaders, investigators, IRBs/ECs, contractors/vendors, societies, associations and company personnel;
    • Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
    • Leads in study design to develop appropriate clinical trials to meet the clinical evidence needs;
    • Contributes to the development and delivery of appropriate Global EGS (Evidence Generation Strategies)/ EDS (Evidence Dissemination Strategies) to support New Product Development and Life-Cycle Management within the assigned platforms, with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), ensuring cross-functional alignment;
    • Ensures input and strong alignment from key regional Clinical R&D leads and other strategically important countries/ regions in the development of the EGS/ EDS;
    • Leads in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, Abstracts, Manuscripts, Clinical Evaluation Reports, etc.;
    • Is responsible for clinical data review to prepare data for statistical analyses and publications;
    • Contributes in clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections;
    • Develops a strong understanding of the pipeline, product portfolio and business needs;
    • Serves as the clinical representative on a New Product Development team;
    • If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center;
    • Manages and oversees ordering, tracking, and accountability of investigational products and trial materials;
    • If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
    • Is responsible for communicating business related issues or opportunities to next management level. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
    • Plans, tracks and manages assigned project budgets to ensure adherence to business plans;
    • Responsibility for the development of Post-Market Clinical Follow-up (PMCF) Plans and Reports as applicable;
    • May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging;
    • Manages and mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency;
    • Performs other duties which may not be specified above as required in order to support the on-going clinical projects assigned;
    • Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed.
    • Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
    • Is 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;

    QUALIFICATIONS

    Education/Experience:

    • A minimum of a Bachelor’s Degree preferably in Biological Science, Nursing, or related discipline, with at least 8 years related scientific/ technical experience, including leadership/ management role within Clinical Research.
    • With a PhD or Master’s Degree, these requirements will be a minimum of 6 years related scientific/ technical experience.

    Functional and Technical Competencies:

    • Medical device experience highly preferred.
    • Thorough understanding of clinical research and processes (GCPs) along with a good understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations.
    • Experience in leading teams to deliver critical milestones.
    • Ability to collaborate across different functions to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives is preferred.
    • Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders is preferred.
    • Experience working well with cross-functional teams is preferred
    • Experience with budget planning, tracking and control is preferred
    • Good written and oral communication skills is required.
    • People management related experience is a plus, but not required.
    • Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO, etc).

    LOCATION & TRAVEL REQUIREMENTS

    • Primary location for this position is Irvine, CA and will require on site work, on average, 2-3 days per week as well as attendance at critical on-site meeting as schedule.
    • Ability to travel (domestic and international) approximately 25% depending on the phase of the program.

    At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

    For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

    Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

    READY TO BE PART OF SOMETHING GREAT? DON'T FORGET TO APPLY. WE WANT YOU!

    PRIMARY LOCATION

    United States-California-Irvine-31 Technology Dr

    ORGANIZATION

    Biosense Webster Inc. (6010)

    JOB FUNCTION

    R&D

  • Industry
    Hospital and Health Care
  • Fun Fact
    We aspire to be the world's healthiest work force, offering group fitness classes, beach volleyball courts, bicycle desks, and more!
  • About Us

    Push the boundaries of science to transform health—and your career.

    Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

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