Clinical Research Manager

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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:

Fueled by innovation at the intersection of biology and technology were 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 thats 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 are searching for the best talent for a Clinical Research Manager to support our Electrophysiology business. This role will work a Flex/Hybrid schedule with 3 days per week onsite in our Irvine CA office.

Purpose:

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

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.
• 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;
• Manages and oversees ordering tracking and accountability of investigational products and trial materials;
• Ensures applicable trial registration (e.g. ) from study initiation through posting of results and support publications as needed;
• Is responsible for teams interface and collaboration with key opinion leaders investigators IRBs/ECs Regulatory agencies contractors/vendors societies associations and company personnel;
• Is responsible for clinical data review to prepare data for statistical analyses and publications;
• May perform monitoring activities including site qualification visits site initiation visits interim monitoring visits or close out visits based on study need;
• In EMEA responsible for Regulatory Affairs related tasks associated with clinical trials and evidence generation.
• Contribute 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 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 study design to develop appropriate clinical trials to meet the clinical evidence needs;
• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;

• 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 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);
• Plans tracks and manages assigned project budgets to ensure adherence to business plans;
• 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;
• Serves as the clinical representative on a New Product Development team;
• Is responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports;
• Conducts review of promotional materials to ensure fair-balance accuracy in clinical claims and messaging;

• 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;
• Manages and mentors resources assigned to designated clinical trials to provide quality deliverables while maintaining optimal efficiency;
• Is responsible for providing performance feedback to direct reports (if applicable) as well as coaching and assistance in their development;
• 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;
• Is 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;
• Manages work independently. Independently solves problems arising during clinical trial execution and will seek guidance for more complex problems as needed.
• May perform other duties assigned as needed;

Requirements:

• Minimum of a Bachelors Degree in Life Science Physical Science Nursing Biological Science or related scientific degree required.

• A minimum of 8 years related scientific/ technical experience including leadership/ management role within Clinical Research.

• Significant previous experience in clinical project leadership across multiple studies/ programs is required.
• Experience working well with cross-functional teams is required.
• A minimum of 1-2 year people management-related experience is required.
• Medical device experience is highly preferred.
• Experience with budget planning tracking and control is preferred.
• Relevant industry certifications is preferred (i.e. CCRA CCRC CCRP RAC CDE GCP ISO 14155 MDR ).
• Clinical/medical background is preferred

Functional and Technical Competencies:

• Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes team dynamics related healthcare market environment clinical trends and global clinical trial regulations;
• Ability to provide scientifically strategic and scientific clinical research input across New Product Development and Life-Cycle Management projects including complex and/ or transformational projects; Proven track record in delivering clinical projects within clinical/ surgical research setting on time within budget and in compliance to SOPs and regulations;
• Strong presentation and technical writing skills;
• Strong written and oral English communication skills;

• Comprehensive understanding of clinical trial regulations across multiple regions;
• Demonstrates competencies in the following area are required:
  • Ability to lead teams to deliver critical milestones including complex projects
  • Strong project management skills with ability to handle multiple projects
  • Strong people management skills
  • Change agent in team development and progression

Leadership Competencies:

Strong leadership required in alignment with J&J Leadership Imperatives:

• Connect Develop strong collaborative relationships with key internal and external stakeholders to ensure development and timely delivery of innovative EGS/ EDS. Create strong and productive partnership with resource providers and vendors.
• Shape - Make recommendations for and actively participate and lead in departmental process improvement efficient use of resources shape the way clinical trial management is conducted and resources are utilized.
• Lead - Continually develop expertise to provide strategic and scientific clinical research capability. Ensure appropriate escalation of compliance issues.
• Deliver - Ensure all deliverables on allocated studies and those of any direct reports are met on time within budget and in compliance to SOPs and regulations. Ensure all sponsored studies have appropriately trained clinical trial leaders/ specialists assigned.

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 & 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 external applicants please contact us via Internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

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

The anticipated base pay range for this position is :

$117000.00 - $201250.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

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: - Experience:

Manager