Associate Director Of Clinical Data Standards

Associate Director of Clinical Data Standards Overview

• The Associate Director of Clinical Data Standards leads enterprise-wide clinical data standards governance and implementation.
• This role ensures compliance with regulatory requirements and industry standards for clinical data management and submission.
• Collaborates across departments to maintain and enhance the clinical data standards library and governance processes.
• Drives adoption of automated validation tools and AI-enabled use cases for data standards.
• Provides training and mentorship to peers and junior staff on data standards concepts and operations.
• Represents the organization in external standards communities and contributes to industry advancements.
• Ensures inspection-ready documentation and traceability for regulatory submissions.
• Leads cross-functional governance bodies and technical working groups to influence standards adoption.

Associate Director of Clinical Data Standards Key Responsibilities & Duties

• Own and maintain the enterprise clinical data standards library across all data architecture layers.
• Author and publish reusable standards specifications and conventions for clinical studies.
• Lead impact assessments and version releases for evolving regulatory and industry standards.
• Operate standards change-control workflows and governance processes end-to-end.
• Develop and deliver training materials to drive consistent standards adoption across teams.
• Collaborate with IT/Data Engineering to standardize system interoperability and validation tools.
• Represent Clinical Data Standards during audits and regulatory inspections.
• Maintain an active presence in external standards communities and contribute to industry discussions.

Associate Director of Clinical Data Standards Job Requirements

• Bachelor's or Master's degree in Life Sciences, Computer Science, Health Informatics, or related field.
• 10+ years of experience in clinical data management or clinical data standards.
• Deep expertise in CDISC standards including CDASH, SDTM, ADaM, and controlled terminology.
• Experience with metadata repositories, standards libraries, and governance infrastructures.
• Strong understanding of regulatory requirements for data standards and submission readiness.
• Proven ability to lead cross-functional governance bodies and technical working groups.
• Excellent written and verbal communication skills for diverse audiences.
• Comfort operating as an individual-contributor expert producing standards deliverables.