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 the 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
All Job Posting Locations:
Irvine, California, United States of America, Jacksonville, Florida, United States of America, Milpitas, California, United States of America
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.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for a Clinical Operations Manager. The role is based on either the campuses in Irvine, CA, Milpitas, CA, or Jacksonville, FL.
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
EXPERIENCE AND SKILLS:
Required:
A 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 proficiency preferred, including (Word, Excel, PowerPoint, and 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.
LI-VY1
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 :
$117,000.00 - $201,250.00
For Bay Area:
$134,000.00 - $231,150.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's 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: - https://www.careers.jnj.com/employee-benefits
