FDA 21 CFR

Part 11 ICH guidelines Document change management Metadata management Metadata creation

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Neisha Camacho/Terra Parsons - No 3rd party candidates Position Summary The Associate Director, Clinical Data Standards and Governance is a hands-on subject-matter expert and standards owner who leads the design, implementation, and lifecycle governance of clinical data standards across the enterprise data value chain — from protocol concept and collection through acquisition, tabulation, analysis, and regulatory submission. This role is the technical backbone of the Enterprise Clinical Data Standards & Regulatory Submission Readiness program, translating governance council decisions into concrete, adopted standards content and driving the metadata, controlled terminology, and validation infrastructure that makes those standards usable at study level. The incumbent personally develops and maintains the standards library (CDASH/eCRF, SDTM, ADaM, Define-XML/SDRG/ADRG, controlled terminology) and the governance mechanics that keep it current — version control, change/exception workflows, regulatory surveillance, and compliance metrics — while partnering across CDM, Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Quality, and IT/Data Engineering to ensure standards are consistently authored once and reused everywhere. This is an individual-contributor leadership role: the person in this seat is expected to do the standards work directly, chair or drive technical working groups, and set technical direction, not simply oversee others doing it. The role also carries responsibility for compliance with applicable corporate and divisional policies and procedures, and for maintaining an active, credible presence in the external CDISC standards community. Key Responsibilities Standards Content Ownership Own and maintain the enterprise standards library across all five layers of the data architecture: Collection (CDASH, eCRF library, edit checks), Acquisition (labs, ECG, imaging, eCOA, biomarker, digital health, external transfer specifications), Tabulation (SDTM domains, sponsor conventions, mappings, controlled terminology, Define-XML, cSDRG), and Analysis (ADaM, analysis metadata, ADRG, TLF interfaces). Maintain a complete and in-depth understanding of all CDISC guidance documents and implementation guides, as well as FDA guidance and regulation on electronic submission of data; keep abreast of industry trends in data mapping, data management, standards compliance methodologies, metadata management, and data warehousing. Author and publish sponsor SDTM/ADaM implementation conventions, controlled terminology mappings, and e

CRF/CDASH

specifications that are reusable across studies and therapeutic areas. Demonstrate extensive understanding of CDASH and SDTM standards and concepts; critically review eCRF designs to ensure compatibility and conformance with

CDASH/SDTM

standards, proactively recognizing and correcting design flaws. Demonstrate extensive understanding of SDTM, controlled terminology, and common coding dictionaries; review SDTM conformance mapping specifications and proactively correct flaws, and provide input and CDISC expertise to cross-functional activities such as mapping of source data to SDTM. Lead impact assessments and version releases when CDISC, regulatory, or internal business requirements change, ensuring controlled, documented rollout with defined effective dates and training. Maintain Define-XML, SDRG, and ADRG templates and conventions to support consistent, submission-ready documentation across the portfolio. Governance, Process & Compliance Ensure personal and team compliance with all applicable corporate and divisional policies and procedures governing clinical data standards and their implementation. Serve as a core technical member (and, where appropriate, chair) of Tier 3 standards working groups (Collection, External Data, SDTM & Submission, ADaM & Analysis, Technology & Automation), preparing proposals for review by the Clinical Data Standards Governance Council. Operate the standards change-control and exception/deviation workflow end to end: intake, functional SME review, council approval, publication, and study-team implementation. Maintain the standards charter, governance council terms of reference, SOPs, and work instructions that keep standards mandatory rather than optional guidance, and keep RACI/decision rights current across CDM, Biostats, Programming, Clinical Ops, Regulatory, Quality, and IT. Run regulatory surveillance for evolving CDISC, FDA, and ICH data standards requirements and translate changes into prioritized updates to the standards library. Represent Clinical Data Standards during audits and regulatory inspections; ensure inspection-ready documentation and full traceability from source data to submission. Technology, Metadata & Automation Own and continuously improve the metadata repository, including release management, version control, lineage/traceability controls, and automated validation rules; manage libraries of CDISC-related metadata, terminology, and related standards within the repository, and provide governance oversight to the Manager, Data Standards to ensure consistency of metadata. Demonstrate knowledge of SDTM/ADaM validation rules and the associated Define.xml requirements; execute standard validation tools and appropriately interpret results, collaborating with other functions to resolve identified issues and ensuring any unresolved issues are appropriately documented (e.g., in the FDA's Data Reviewer's Guides). Partner with IT/Data Engineering and Biometrics to standardize system interoperability across EDC, external data platforms, and downstream tabulation/analysis tools. Drive adoption of automated validation and standards-compliance tooling, and identify AI-enabled use cases (e.g., automated mapping, spec generation, QC) that increase reuse and reduce cycle time. Maintain the standards-compliance dashboard and report enterprise-level adoption, quality, speed, and readiness metrics to program leadership and the Governance Council. Adoption, Enablement & Cross-Functional Partnership Develop and deliver role-based training, study implementation playbooks, and office hours / community-of-practice sessions to drive consistent standards adoption across study teams and CROs. Effectively mentor peers, the Manager, Data Standards, Senior Data Standards Analysts, and Data Standards Analysts on data standards concepts and functional operations; train new Data Standards Analysts on the processes and systems used to manage and implement standards. Define and enforce CRO/vendor data standards requirements; review vendor deliverables (transfer specifications, mapping specs) for conformance. Act as the standards subject-matter expert in cross-functional forums, providing guidance to study teams, Biostatistics, Statistical Programming, and CRO partners on standards interpretation and implementation; diplomatically and persuasively represent the interests of the Data Standards group in cross-functional initiatives. Capture pilot lessons learned and feed continuous-improvement recommendations back into the standards library and governance processes. External Standards Engagement Maintain an external reputation as a clinical data standards expert and represent the organization in the broader CDISC community. Coordinate consolidated review comments from the Data Standards group and Statistical Programming for applicable CDISC standards released for public review. Submit at least one abstract per year for presentation at a CDISC Interchange. Success Measures Performance in this role is assessed against enterprise standards KPIs spanning adoption (e.g., studies and vendor transfers on standard), quality (deviations, critical findings, repeat defects), speed (CRF build cycle time, mapping/spec reuse, DB lock-to-submission-ready timeline), and readiness (first-pass QC, traceability completeness, inspection-ready documentation, exception turnaround). Qualifications Bachelor's or Master's degree in Life Sciences, Computer Science, Health Informatics, or a related discipline. 10+ years of progressive experience in clinical data management or clinical data standards, with demonstrated ownership of enterprise-level standards content (not solely study-level execution). Deep, hands-on expertise in CDISC standards — CDASH, SDTM, ADaM, controlled terminology — and Define-XML/SDRG/ADRG authoring. Working knowledge of clinical data collection and acquisition technologies (EDC/Rave, RTSM, eCOA, external/vendor data transfers) sufficient to define standards and specifications, though this role is standards-focused rather than systems-administration-focused. Experience building or operating a metadata repository, standards library, or comparable governance infrastructure, including version control and validation frameworks. Demonstrated experience authoring SOPs, work instructions, and governance charters, and operating change-control or exception workflows in a regulated environment. Solid understanding of

GCP, ICH, 21 CFR

Part 11, and global regulatory expectations as they relate to data standards, traceability, and submission readiness (NDA, BLA, MAA). Proven ability to lead or contribute to cross-functional governance bodies and technical working groups, influencing without direct authority across CDM, Biostatistics, Programming, Clinical Operations, Regulatory, Quality, and IT. Strong written and verbal communication skills, with experience producing governance documentation, training materials, and dashboards for varied audiences up to senior leadership. 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