Associate Director, Clinical Data Management & Systems | Jacksonville, FL

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Clinical Data Management

Job Category:

Professional

All Job Posting Locations:

Jacksonville, Florida, United States of America

Job Description:

About Vision

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

We are searching for the best talent for an Associate Director, Clinical Data Management & Systems to join our J&J Vision team.  This position is based in Jacksonville, FL.  Other J&J Vision locations may be considered for the ideal candidate.

Purpose:

As a member of the Statistics and Clinical Data Management Leadership Team, the Associate Director, Clinical Data Management & Systems will lead data management and system support across the J&J Vision portfolio, ensuring reliable, compliant, and high-quality clinical trial data. This role sets strategy for data standards, databases, systems, vendor oversight, and timely delivery of clean data to support study execution, analysis, and regulatory submissions. The Associate Director will work closely with the Global Head of Statistics and Clinical Data Management to ensure alignment in strategy, resource planning and excellence in execution. Collaboration with the departments of Statistics, Clinical Operations, Clinical Science, Regulatory Affairs, and external partners is crucial to strengthen operational excellence, inspection readiness, and continuous improvement across the Surgical Vision and Vision Care businesses, an outstanding opportunity to shape critical work across the portfolio.

You will be responsible for:

• Provide strategic leadership for Clinical Data Management across the medical devices portfolio in support of Johnson & Johnson Vision’s clinical, regulatory, and business priorities.
• Oversee planning, execution, and delivery of core data management activities, including database build, edit checks, data review, coding, reconciliation, and database locks.
• Establish and maintain standards, processes, and system workflows that enable efficient, consistent, and compliant study execution.
• Act as the subject matter expert for clinical data management systems supporting Clinical Operations (e.g. CTMS) and Clinical Science (e.g. SDTM) and processes, advising on data quality, system capabilities, and operational best practices.
• Drive data quality and integrity through proactive review, issue management, metrics, and risk-based methods that support timely clinical decisions.
• Lead oversight of external vendors and technology partners to ensure strong service, on-time delivery, and compliance with study and regulatory requirements.
• Collaborate with Clinical Operations, Clinical Science, Statistics, Statistical Programming, Medical Safety, and Regulatory Affairs to support startup, study conduct, analysis, and submission readiness.
• Support audits and regulatory inspections by maintaining inspection-ready documentation, compliant processes, and effective responses to data management questions and audit findings.
• Build and develop internal and external Clinical Data Management team members through clear goals, coaching, training, and performance support.
• Advance continuous improvement and harmonization of data management processes, systems, and standards to increase efficiency and support evolving business needs.
• Ensure all activities are performed in accordance with applicable regulations, GCP, company policies, and quality expectations. 

Qualifications:

• Bachelor’s degree required; an advanced degree in life sciences, health sciences, data management, information systems, or a related field is strongly preferred.
• Minimum of 8 years relevant Clinical Data Management experience in clinical research (pharmaceutical, biotechnology, or medical devices / diagnostics industry) is required.
• People and/or functional leadership experience, including management of a team is required.
• Demonstrated leadership of clinical data management activities across multiple clinical studies, including database setup, edit checks, data review, coding, reconciliation, and database lock is required.
• Hands-on experience with electronic data capture, clinical systems, and related technologies; familiarity with at least one EDC system is essential.
• Strong knowledge of CDISC data standards (SDTM & ADaM) is required; experience with data integrations, and process automation is preferred.
• Solid understanding of GCP, and applicable global regulations (e.g. ISO 14155, 21 CFR Part 11) is required.
• Experience overseeing external vendors, managing contractors and collaborating effectively with cross-functional stakeholders is strongly preferred.
• Exposure supporting audits, inspections, and regulatory submissions.
• Excellent oral and written communication, organization, and problem-solving skills.
• Position is based in Jacksonville, Florida, though other J&J Vision locations may be considered for the ideal candidate.  Fully remote work is not available.
• Ability to travel domestically up to 25% may be needed.

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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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Required Skills:

Clinical Data Management, Clinical Research, GCP Auditing, Leadership

 

 

Preferred Skills: