Associate Director, Clinical Data Management Trial Lead

Associate Director leading end-to-end clinical data management for assigned trials at Merck. Accountable for data quality, integrity, and regulatory compliance across the trial lifecycle, serving as primary data management contact for cross-functional teams and contributing to process improvement.

Responsibilities

• Lead clinical data management activities from study start-up through database lock and archival
• Oversee data collection design, validation strategies, and query resolution across multiple data sources
• Manage risk-based data quality oversight and implement mitigation plans for identified issues
• Develop and maintain data management deliverables including DMP, DVP, eCRFs, and specifications
• Provide oversight, mentoring, and training to Clinical Data Managers and External Data Specialists

Requirements

• Deep understanding of clinical development lifecycle, data flow, and cross-functional dependencies
• Strong command of data management principles, processes, and regulatory requirements
• Experience with CDISC standards (SDTM, CDASH) and clinical data systems
• Knowledge of 21 CFR Part 11, ICH-GCP, and applicable regulatory standards
• Leadership experience with clinical data management teams and external partners
• Proficiency in data validation, reconciliation, and quality assurance practices