Director, Clinical Data Management

Job Description

REQUIREMENTS

• Bachelor’s or Master’s degree in a scientific subject area
• Minimum of 8 years CDM experience in pharmaceutical, biotech, or CRO settings
• At least 4 years of line management experience
• Required global or international experience
• Strong experience in cross-functional leadership, clinical trial execution, and vendor oversight
• Sophisticated knowledge of CDM processes, EDC systems, and database programming
• In-depth knowledge of FDA regulations, GCP, GCDMP, CDASH/CDISC, and ICH guidelines

Preferred

• Experience with data visualization tools such as Elluminate

RESPONSIBILITIES

• Oversee CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development
• Provide oversight of CROs, vendors, and internal teams to maintain quality standards
• Ensure CDM documentation, SOPs, and processes support regulatory compliance with FDA, GCP, ICH, and GCDMP
• Partner within Biometrics and Data Science and cross-functionally on data management issues
• Recruit, develop, and provide leadership to CDM staff and consultants
• Support resource planning, budget forecasting, timelines, and issue resolution
• Identify risks in clinical trial data management and propose solutions
• Maintain an inspection-ready environment and support regulatory readiness

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