Director, Clinical Data Management

Role overview Direct clinical data management operations for clinical research programs, overseeing people, project delivery, and quality across the department. The director also contributes technical leadership, sponsor relationships, business development, and strategic planning while improving delivery efficiency and maintaining regulatory compliance.

Responsibilities - Lead day-to-day data management operations, staffing, workload planning, and team development. - Guide project execution and resource allocation, ensuring high-quality work and keeping senior leadership informed of status. - Serve as a subject matter expert in cross-functional work and communicate with sponsors, vendors, and other partners. - Contribute to business development, capabilities presentations, proposals, and contract discussions. - Manage department and study budgets, and develop and analyze performance metrics to identify trends and corrective actions. - Improve procedures, templates, training, timelines, and cost efficiency while meeting quality and regulatory requirements.

Requirements - Bachelor’s degree in an applied or life science and at least 12 years of clinical trials experience, including 10 years in data management, or equivalent education and experience. - Extensive clinical data management experience, preferably in a contract research setting. - Demonstrated leadership of data management operations, including budgeting, forecasting, project and process management, and team development. - Expert knowledge of ICH Good Clinical Practice guidance and US Part 11 requirements. - Training and experience with CDISC CDASH and SDTM. - Strong planning, communication, collaboration, and problem-solving skills, with a focus on timely, high-quality work.

Nice to have - Advanced degree and direct supervisory experience. - Ophthalmology experience; programming or medical coding skills; familiarity with Oracle Clinical Life Sciences Suite or iMedNet.