Associate Director Clinical Data Standards & Governance

Contact: Neisha Camacho/Terra Parsons -
No 3rd party candidates

Position Summary

The Associate Director, Clinical Data Standards & Governance is a hands-on SME responsible for the design, implementation, and lifecycle governance of clinical data standards from protocol/data collection through acquisition, tabulation, analysis, and regulatory submission.

This individual owns and develops the enterprise standards library, including CDASH/eCRF, SDTM, ADaM, Define-XML/SDRG/ADRG, controlled terminology, metadata, and validation infrastructure. This is an individual-contributor leadership role requiring direct standards work, technical leadership, cross-functional influence, and active engagement with the CDISC community.

Key Responsibilities

Standards & Governance

• Own standards across Collection (CDASH/eCRF), Acquisition (labs, ECG, imaging, eCOA, biomarkers/external data), Tabulation (SDTM, mappings, terminology, Define-XML/cSDRG), and Analysis (ADaM, metadata, ADRG/TLF interfaces).
• Maintain expertise in CDISC guidance/implementation guides and FDA electronic submission requirements.
• Author reusable SDTM/ADaM conventions, terminology mappings, and CDASH/eCRF specifications.
• Review eCRF designs and SDTM mappings for standards conformance and correct design/mapping issues.
• Lead impact assessments and releases resulting from CDISC, regulatory, or business changes.
• Maintain Define-XML, SDRG, and ADRG templates and conventions.
• Lead/participate in technical standards working groups and manage change-control/exception workflows.
• Maintain governance charters, SOPs, work instructions, RACI, and decision rights.
• Monitor CDISC, FDA, and ICH requirements and translate changes into standards updates.
• Support audits/inspections and ensure traceability from source through submission.

Technology, Metadata & Automation

• Own/improve the metadata repository, including release/version control, lineage/traceability, terminology, and automated validation.
• Apply SDTM/ADaM validation rules and Define.xml requirements; execute validation tools, interpret findings, and coordinate resolution/documentation.
• Partner with IT/Data Engineering and Biometrics on interoperability across EDC, external data, and downstream analysis platforms.
• Drive automated validation/compliance tools and AI-enabled opportunities including mapping, specification generation, and QC.
• Track standards adoption, quality, speed, and submission-readiness metrics.

Adoption & Leadership

• Develop training, implementation playbooks, and standards guidance for study teams and CROs.
• Mentor Data Standards colleagues and train analysts on standards processes/systems.
• Define CRO/vendor standards requirements and review transfer/mapping specifications.
• Serve as standards SME across CDM, Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Quality, IT, and CRO partners.
• Drive continuous improvement based on study/pilot lessons learned.
• Represent the organization in the CDISC community, coordinate comments on standards under public review, and submit at least one annual CDISC Interchange abstract.

Success Measures

Performance is measured through standards KPIs covering adoption, quality, speed, and readiness, including deviations, reuse, cycle times, first-pass QC, traceability, inspection readiness, and exception turnaround.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Computer Science, Health Informatics, or related field.
• 10+ years of clinical data management/standards experience, including enterprise-level standards ownership.
• Deep hands-on expertise in CDASH, SDTM, ADaM, controlled terminology, and Define-XML/SDRG/ADRG.
• Knowledge of EDC/Rave, RTSM, eCOA, and external/vendor data transfers.
• Experience with metadata repositories/standards libraries, version c