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

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 .

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.

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About Vision

Fueled 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 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 Visions 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:

• Bachelors 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. ISOCFR 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 or contact AskGS to be directed to your accommodation resource.

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