Manager, Project Management Clinical EP

Johnson & Johnson

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profile Job Location:

Irvine, CA - USA

profile Monthly Salary: $ 117000 - 201250
Posted on: 3 hours ago
Vacancies: 1 Vacancy

Job Summary

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

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:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

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 Project 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 Project 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:

Leadership & Team Development:

  • Coach and guide Study Core Teams to understand how their timelines deliverables and decisions support program strategy business objectives and broader portfolio needs.
  • Provide daytoday leadership to project team members fostering strong planning risk management and disciplined execution while mentoring the project management team on best practices.
  • Promote and ensure consistent use of project management processes tools templates and operational standards across studies and programs.

Project & Program Oversight:

  • Build maintain and integrate project and program timelines ensuring alignment with strategic priorities resource plans business goals and critical path.
  • Partner with Clinical Study Leads Program Leads and functional Core Team leads to validate planning assumptions ensure crossfunctional alignment and support predictable delivery.
  • Track progress against milestones and KPIs; forecast impacts identify and escalate risks and drive mitigation and recovery plans across the program portfolio.

Communication & Governance:

  • Communicate project and program statusincluding timeline health risks dependencies business implications and decision needsto Study and Program Core Teams PMO and Scientific Affairs leadership.
  • Prepare scenario analyses impact assessments and decisionsupport materials to enable timely programlevel governance decisions.
  • Serve as project manager for multiple studies or crossfunctional program workstreams acting as a reliable trusted source of current project information for key stakeholders.

CrossFunctional Collaboration:

  • Partner closely with Scientific Affairs Clinical Regulatory Data Management Biostatistics Program Management Office and other stakeholders to integrate functional plans into cohesive program timelines.
  • Drive clarity on strategy roles and responsibilities dependencies and milestone ownership within and across study teams to ensure strong crossfunctional alignment.
  • Collaborate with vendors CROs and external partners to ensure their deliverables and timelines support internal strategy and program objectives.

Operational Excellence:

  • Build and enhance a resource management tool to support accurate workload forecasting capacity planning and alignment of resources with program priorities.
  • Support development and reconciliation of study budgets and forecasts ensuring alignment between project needs program plans and business priorities.
  • Drive operational improvements through standardization process optimization and adoption of enhanced planning and project management tools.
  • Communicate businessrelated issues or opportunities to the next management level and ensure personal and company compliance with all Federal State local and company regulations policies and procedures.
  • Demonstrate a strong understanding of the clinical pipeline product portfolio and business context to support strategic decisionmaking and project prioritization.
  • Manage work independently solving daytoday execution issues and escalating more complex challenges when appropriate.
  • Perform other duties as assigned to support clinical research operations program management needs and organizational goals.

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 and building consensus with cross-functional teams is required.
  • Clinical/medical background is required.
  • Medical device clinical research 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 ).
  • A minimum of 1-2 year people management-related experience is preferred.

Functional and Technical Competencies:

  • Strong understanding of clinical research processes evidence generation product development and global clinical trial regulations (ICHGCP ISO 14155).
  • Proven ability to manage complex clinical programsintegrating timelines budgets risks and crossfunctional deliverables to ensure compliant ontime execution.
  • Excellent written and verbal communication skills with the ability to present clearly create highquality technical documents and drive alignment across Core Teams and leadership.
  • Demonstrated leadership in guiding teams through key milestones influencing without authority and fostering continuous improvement and standardized project management practices.
  • Strong project and program management skills able to balance multiple workstreams support team development and act as a change agent for process and operational enhancements.

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:

Analytical Reasoning Budgeting Clinical Trial Management Systems (CTMS) Clinical Trials Compliance Management Contract Management Execution Focus Fact-Based Decision Making Laboratory Operations Mentorship Process Improvements Project Integration Management Research and Development Research Ethics Standard Operating Procedure (SOP) Technical Credibility

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 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

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 unique...
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About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more

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