Clinical Operations Manager - Johnson and Johnson

Johnson & Johnson Vision Care, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Clinical Operations Manager located in Jacksonville, FL.

At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That's why, through our operating companies, we've developed solutions for every stage of life-to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world's leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good, and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.

Position Summary:

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/Clinicians to ensure that project deliverables are met. Manages relationships externally with Strategic Partners, including universities, research institutions, and CROs.

Essential Functions/Responsibilities:

1. 1 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 (30%).
2. 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 (30%).
3. 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 (15%).
4. Responsible for the selection of Contract Resource Organizations (CRO) and oversight of contracts, timelines, and budgets, when applicable (10%).
5. Manage and improve clinical trial processes, including benchmarking and leveraging across other J&J companies (10%).

6. Perform other related duties as assigned by management (5%). Qualifications:

Required:

• A minimum of a Bachelors Degree in a Scientific Discipline

• A minimum of 5-8 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 skills.

• 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.

At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .