Clinical Operations Manager at Johnson & Johnson

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 OperationsJob Sub Function: Clinical Trial Project ManagementJob Category:ProfessionalAll Job Posting Locations:Irvine California United States of America Jacksonville Florida United States of America Milpitas California United States of AmericaJob Description:About VisionFueled 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 workAccountable for the preparation and finalization of key clinical documents which include the clinical protocol informed consent case report form and other essential study documentsManage 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 devicesResponsible for the selection of Contract Resource Organizations (CRO) and oversight of contracts timelines and budgets when applicableManage and improve clinical trial processes including benchmarking and leveraging across other J&J companiesPerform other related duties as assigned by managementQualifications:Education: Bachelors degree is requiredEXPERIENCE AND SKILLS:Required:A minimum 8 years of work experienceExperience required within any of the following areas: distribution manufacturing logistics supply chain customer service healthcareSAP knowledgeProficiency in MS Office Suite proficiency preferred including (Word Excel PowerPoint and Outlook)Knowledge of Warehouse Management SystemsDemonstrated initiative creativity assertiveness and proactive communicationStrong interpersonal and communication skillsPreferred:Kaizen/Greenbelt LEAN CertificationValidated understanding of enterprise resource platforms and warehouse management systemsExperience building reports with visualization programs e.g. PowerBI and/or TableauExperience Working in highly regulated industriesAbility and capability to lead or support projectsProcess Excellence training and/or certification or APICS certificationProject Management Certification/ExperienceSales or Sales support role experienceInventory Management experience sterile processing OR support or clinical experience in a hospital environmentWarehouse Management System (WMS) and/or Transportation systems (TMS) experienceKaizen/Greenbelt LEAN CertificationOther:10% domestic travel to other sites as needed is required.This role is exempt Not overtime eligibleJohnson & 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-VY1#LI-HybridRequired 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 CredibilityThe anticipated base pay range for this position is :$117000.00 - $201250.00For Bay Area: $134000.00 - $231150.00Additional 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 yearSick 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 yearHoliday pay including Floating Holidays 13 days per calendar yearWork Personal and Family Time - up to 40 hours per calendar yearParental Leave 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave 80 hours in a 52-week rolling period10 daysVolunteer Leave 32 hours per calendar yearMilitary Spouse Time-Off 80 hours per calendar yearFor additional general information on Company benefits please go to: - Experience:Manager Key Skills Six Sigma,Lean,Management Experience,Process Improvement,Microsoft Outlook,Analysis Skills,Warehouse Management System,Operations Management,Kaizen,Leadership Experience,Supervising Experience,Retail Management Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 117000 - 201250