Associate Director, Clinical Data Management

Merck seeks an Associate Director of Clinical Data Management to oversee data standards and governance across global clinical programs. The role involves defining CDISC-aligned data collection standards, leading therapeutic area standards teams, training cross-functional staff, and ensuring regulatory compliance throughout the clinical lifecycle.

Responsibilities

• Define and maintain data collection standards aligned with CDISC and regulatory guidance across clinical lifecycle phases
• Lead Therapeutic Area Standards Teams, delivering training and mentoring to junior staff on standards and best practices
• Support governance reviews, audits, and inspections; provide first-line oversight of study team changes to library forms
• Engage in industry forums to monitor emerging standards, technologies, and regulatory trends affecting company implementations
• Work as core design team member on assigned studies, ensuring clinical data standards align with enterprise requirements

Requirements

• Deep expertise in CDISC clinical data standards (CDASH, SDTM, Controlled Terminology)
• Demonstrated knowledge of clinical development trial processes and worldwide regulatory data management requirements
• Strong understanding of electronic data capture (EDC), eCRF design, and clinical database development
• Knowledge of at least one therapeutic area with ability to drive consistency across studies
• Familiarity with ICH and GCP guidelines and drug discovery processes
• Experience interpreting study protocols and translating requirements into data standard definitions
• Excellent cross-functional communication and leadership through influence