Clinical Data Management

Job Title: Director, Clinical Data Standards

Location: Remote - United States

Type: Full Time

Our Client is seeking a dynamic and visionary Director, Clinical Data Standards to lead the strategy, governance, and evolution of global clinical data standards across the full clinical data lifecycle. This senior leadership role is ideal for a seasoned expert who thrives at the intersection of data standards, clinical technology, cross‑functional collaboration, and regulatory excellence. The Director will shape the long‑term standards vision, ensure high‑quality and interoperable data, and drive adoption of scalable processes and technologies across global teams.

Key Responsibilities

Strategic Leadership

• Define and execute the global strategy for clinical data standards, processes, and technologies across all phases of the clinical data continuum.
• Lead the development and continuous improvement of a comprehensive standards library spanning data collection, validation, transformation, analysis, and reporting.
• Collaborate with cross‑functional leadership to ensure seamless alignment and broad adoption of standards across programs.

Standards Development & Governance

• Oversee governance processes to ensure consistent application of standards and timely assessment of enhancements or deviations.
• Provide strategic oversight of systems, tools, and vendor partnerships supporting standards lifecycle management and compliance monitoring.
• Serve as a subject matter expert on standards during regulatory interactions and internal reviews.

Operational & Technical Expertise

• Support standards related to eCRFs, edit checks, controlled terminology, ADaM/TLFs, and other metadata-driven components.
• Provide authoritative guidance on clinical data systems such as EDC, eCOA, IRT, CDR, MDR, and analytics environments.
• Monitor and interpret emerging trends, new technologies, and evolving regulatory expectations impacting clinical data standards.

Industry Engagement

• Represent the organization in external forums (e.g., CDISC, PhUSE, Transcelerate, SCDM), contributing to industry‑wide standards evolution.
• Drive internal awareness and implementation of regulatory guidance and submission standards.
• Lead, mentor, and develop a global team responsible for standards development and governance.
• Build strong partnerships with internal stakeholders, CROs, and strategic partners to support consistent standards adoption.
• Promote a culture of innovation, continuous improvement, and knowledge sharing across the organization.

Qualifications & Experience

• Bachelor’s or Master’s degree in life sciences, data science, analytics, or a related discipline.
• 12+ years of experience in clinical data management, clinical programming, or related roles within the pharmaceutical or healthcare industry.
• Deep expertise in established standards frameworks (e.g., CDISC, HL7, OMOP, ICH, ISO) and associated regulatory requirements.
• Proven success in developing, managing, and governing clinical data standards libraries.
• Strong technical knowledge of clinical data capture systems and statistical programming languages (e.g., SAS, R, Python).
• Demonstrated ability to lead large global teams and influence senior leadership.
• Experience driving organization‑wide process transformation and implementing scalable standards solutions.
• Excellent communication, problem‑solving, stakeholder management, and conflict‑resolution skills.

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