Senior Director, Clinical Data Management. - Hybrid

Senior Director leading Merck's Global Clinical Data Standards team to establish governance frameworks, oversee data collection standards aligned with industry regulations, and manage strategic initiatives across clinical development. Reports to leadership, manages teams, and represents the organization in industry forums.

Responsibilities

• Oversee teams defining and maintaining standard data collection definitions aligned with industry standards and health authority regulations
• Lead and prioritize standards governance deliverables, coordinating efforts across teams and managing resource planning
• Provide strategic direction on clinical data standards training, mentoring, and best practices delivery
• Act as escalation point for governance decisions and study-level design issues
• Lead cross-functional strategic projects and serve as industry representative maintaining external networks

Requirements

• Extensive experience managing and governing clinical information standards and their implementation
• Deep knowledge of CDISC, CDASH, SDTM, ADaM, HL7, and regulatory submission requirements
• Strong understanding of clinical development processes, data management, and worldwide regulatory requirements
• Advanced knowledge across multiple therapeutic areas with ability to drive consistency
• Familiarity with ICH and GCP guidelines and drug discovery processes
• Demonstrated expertise in people management, budgeting, and cross-functional leadership