Associate Director Clinical Data Standards & Governance

Contact:
Neisha Camacho/Terra Parsons - teamnt

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 eCRF/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.

Maintai…