Johnson & Johnson MedTech
Clinical Operations Manager
Johnson & Johnson MedTech, Milpitas, California, United States, 95035
Clinical Operations Manager
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Johnson & Johnson MedTech
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 breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
Professional
Job Posting Locations:
Irvine, California; Jacksonville, Florida; Milpitas, California
Job Description About Vision
– 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 on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting‑edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime. Learn more at https://www.jnj.com/medtech
Purpose:
The Clinical Operations Manager develops strategies to address complex clinical issues. He/she manages the strategic elements of study conduct, ensuring that operating procedures and company policies are followed. Develops and manages timelines, resourcing and budget for all JJV clinical trials. As spokesperson and technical expert for clinical operations, provides compelling rationale for decisions and presents complex strategies in a clear message.
Using the Clinical Operations Manager’s conceptual knowledge of all R&D functions, drives innovation within functional area. Establishes key operating practices for department/project while ensuring cross‑functional synergy. Builds cross‑functional and cross‑departmental support for innovative solutions and mentors/facilitates successful team behavior. Partners with Platform Managers and Research Optometrists/Ophthalmologist/Clinicians to ensure that project deliverables are met. Manages relationships externally with Strategic Partners, including universities, research institutions, and CROs.
You Will Be Responsible For
Own processes and information required to execute and support the clinical trial including clinical trial project plan, project timelines, resourcing, budget plans, and statements of work
Accountable for the preparation and finalization of key clinical documents which include the clinical protocol, informed consent, case report form, and other essential study documents
Manage study conduct, ensuring that operating procedures and company policies are followed and that trials meet all applicable Regulations and Guidelines required to gain approval for JJV medical devices
Responsible for the selection of Contract Resource Organizations (CRO) and oversight of contracts, timelines, and budgets, when applicable
Manage and improve clinical trial processes, including benchmarking and leveraging across other J&J companies
Perform other related duties as assigned by management
Qualifications Education:
Bachelor’s degree is required.
Required Experience and Skills
Minimum 8 years of work experience
Experience required within any of the following areas: distribution, manufacturing, logistics, supply chain, customer service, healthcare
SAP knowledge
Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook)
Knowledge of Warehouse Management Systems
Demonstrated initiative, creativity, assertiveness, and proactive communication
Strong interpersonal and communication skills
Preferred
Kaizen/Greenbelt, LEAN Certification
Validated understanding of enterprise resource platforms and warehouse management systems
Experience building reports with visualization programs, e.g., PowerBI and/or Tableau
Experience working in highly regulated industries
Ability and capability to lead or support projects
Process Excellence training and/or certification or APICS certification
Project Management Certification/Experience
Sales or sales support role experience
Inventory management experience, sterile processing, OR support or clinical experience in a hospital environment
Warehouse Management System (WMS) and/or Transportation systems (TMS) experience
Kaizen/Greenbelt, LEAN Certification
Other
10% domestic travel to other sites as needed is required.
This role is exempt – not overtime eligible.
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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Pay Range Base: $117,000 – $201,250.
Bay Area: $134,000 – $231,150.
Benefits
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (48 hours if residing in Colorado; 56 hours if residing in Washington)
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 period (10 days)
Volunteer leave – 32 hours per calendar year
Military spouse time‑off – 80 hours per calendar year
Additional general information on company benefits: https://www.careers.jnj.com/employee-benefits
#J-18808-Ljbffr
–
Johnson & Johnson MedTech
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 breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
Professional
Job Posting Locations:
Irvine, California; Jacksonville, Florida; Milpitas, California
Job Description About Vision
– 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 on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting‑edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime. Learn more at https://www.jnj.com/medtech
Purpose:
The Clinical Operations Manager develops strategies to address complex clinical issues. He/she manages the strategic elements of study conduct, ensuring that operating procedures and company policies are followed. Develops and manages timelines, resourcing and budget for all JJV clinical trials. As spokesperson and technical expert for clinical operations, provides compelling rationale for decisions and presents complex strategies in a clear message.
Using the Clinical Operations Manager’s conceptual knowledge of all R&D functions, drives innovation within functional area. Establishes key operating practices for department/project while ensuring cross‑functional synergy. Builds cross‑functional and cross‑departmental support for innovative solutions and mentors/facilitates successful team behavior. Partners with Platform Managers and Research Optometrists/Ophthalmologist/Clinicians to ensure that project deliverables are met. Manages relationships externally with Strategic Partners, including universities, research institutions, and CROs.
You Will Be Responsible For
Own processes and information required to execute and support the clinical trial including clinical trial project plan, project timelines, resourcing, budget plans, and statements of work
Accountable for the preparation and finalization of key clinical documents which include the clinical protocol, informed consent, case report form, and other essential study documents
Manage study conduct, ensuring that operating procedures and company policies are followed and that trials meet all applicable Regulations and Guidelines required to gain approval for JJV medical devices
Responsible for the selection of Contract Resource Organizations (CRO) and oversight of contracts, timelines, and budgets, when applicable
Manage and improve clinical trial processes, including benchmarking and leveraging across other J&J companies
Perform other related duties as assigned by management
Qualifications Education:
Bachelor’s degree is required.
Required Experience and Skills
Minimum 8 years of work experience
Experience required within any of the following areas: distribution, manufacturing, logistics, supply chain, customer service, healthcare
SAP knowledge
Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook)
Knowledge of Warehouse Management Systems
Demonstrated initiative, creativity, assertiveness, and proactive communication
Strong interpersonal and communication skills
Preferred
Kaizen/Greenbelt, LEAN Certification
Validated understanding of enterprise resource platforms and warehouse management systems
Experience building reports with visualization programs, e.g., PowerBI and/or Tableau
Experience working in highly regulated industries
Ability and capability to lead or support projects
Process Excellence training and/or certification or APICS certification
Project Management Certification/Experience
Sales or sales support role experience
Inventory management experience, sterile processing, OR support or clinical experience in a hospital environment
Warehouse Management System (WMS) and/or Transportation systems (TMS) experience
Kaizen/Greenbelt, LEAN Certification
Other
10% domestic travel to other sites as needed is required.
This role is exempt – not overtime eligible.
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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
Pay Range Base: $117,000 – $201,250.
Bay Area: $134,000 – $231,150.
Benefits
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (48 hours if residing in Colorado; 56 hours if residing in Washington)
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 period (10 days)
Volunteer leave – 32 hours per calendar year
Military spouse time‑off – 80 hours per calendar year
Additional general information on company benefits: https://www.careers.jnj.com/employee-benefits
#J-18808-Ljbffr