Clinical Operations Manager

Johnson & Johnson; Jacksonville (FL); On-site; USD 115,000 - 197,000; Full time

Job summary

A leading healthcare company is seeking a Clinical Operations Manager in Jacksonville, FL to drive clinical trial strategies and manage project timelines and resources. This role requires a strong background in clinical research and will involve collaboration with cross-functional teams to ensure compliance in medical device trials.

Benefits

Annual performance bonus

Medical, dental, vision benefits

Retirement plan (401(k))

Vacation and Sick time

Qualifications

• Minimum 8-10 years of experience in Clinical Research in a regulated industry.
• Complete understanding of Good Clinical Practice (GCP).
• Experience in people management preferred.

Responsibilities

• Own processes to execute and support clinical trials with project plans and timelines.
• Accountable for key clinical documents like protocols and consent forms.
• Ensure trials meet applicable regulations and guidelines.

Skills

Communication

Organizational

Interpersonal skills

Negotiation

Education

Bachelors Degree in a Scientific Discipline

Master’s or Ph.D. Degree in Scientific Discipline

Job description

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
• Broad understanding of medical devices/instrumentation used in ophthalmology
• Broad based technical knowledge and skills in diverse areas of business (e.g., Operations, QA, laboratory, regulatory, project management, etc.)
• Strategic & tactical clinical and business knowledge to gain approval and ensure maintenance of legal marketing status of all products

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 and 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, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$115,000-$197,000

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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 and 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, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.