Clinical Operations Manager

Irvine, CA - USA

Monthly Salary: $ 117000 - 201250

Posted on: 30+ days ago

Vacancies: 1 Vacancy

The job posting is outdated and position may be filled

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

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 were 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 thats 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 patients lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at 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 Managers 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: Bachelors 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 internal employees contact AskGS to be directed to your accommodation resource.

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#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

For Bay Area:

$134000.00 - $231150.00

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