Clinical Operations Manager

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:

Jacksonville, Florida, United States of America

Job Description:

We are searching for the best talent to join our Vision team as a Clinical Operations Manager located in Jacksonville, FL.

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

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

Required:

•  A minimum of a Bachelors Degree in a Scientific Discipline
•  A minimum of 8-10 years of experience in Clinical Research in a medical device or pharmaceutical regulated industry
•  Complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP)
•  Strong communication, organizational and interpersonal skill
•  Ability to negotiate effectively and influence peers, affiliates, and Regulatory agencies to ensure that regulatory and business needs are met

Preferred:

•  Master’s or Ph.D. Degree in Scientific Discipline preferred
•  A minimum of 2 years’ experience as a clinical research associate
•  A minimum of 2 years of experience in people management
•  Br