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

Johnson & Johnson Innovative Medicine•Jacksonville, FL

1d•Hybrid

About The Position

This position is for an Associate Director, Clinical Data Management & Systems within the J&J Vision team, based in Jacksonville, FL. The role involves leading data management and system support for the J&J Vision portfolio, ensuring high-quality, compliant clinical trial data. The Associate Director will set strategy for data standards, databases, systems, vendor oversight, and timely data delivery for study execution, analysis, and regulatory submissions. This role requires close collaboration with the Global Head of Statistics and Clinical Data Management, as well as other departments like Statistics, Clinical Operations, Clinical Science, and Regulatory Affairs, to enhance operational excellence and inspection readiness across the Surgical Vision and Vision Care businesses.

Requirements

Bachelor’s degree required.
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.
Solid understanding of GCP, and applicable global regulations (e.g. ISO 14155, 21 CFR Part 11) is required.
Excellent oral and written communication, organization, and problem-solving skills.

Nice To Haves

An advanced degree in life sciences, health sciences, data management, information systems, or a related field is strongly preferred.
Experience with data integrations, and process automation is preferred.
Experience overseeing external vendors, managing contractors and collaborating effectively with cross-functional stakeholders is strongly preferred.
Exposure supporting audits, inspections, and regulatory submissions.

Responsibilities

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.