Lead, Clinical Data Standards & Governance

Penfield Search Partners Ltd; Fairfield (CT); On-site; USD 150,000 - 190,000; Full time

Job summary

Penfield Search Partners Ltd in Connecticut is seeking an Associate Director, Clinical Data Standards and Governance to lead design, implementation, and lifecycle governance of clinical data standards across the enterprise data value chain—from protocol concept and collection through regulatory submission.

This role personally develops and maintains the standards library (CDASH/eCRF, SDTM, ADaM, Define-XML/SDRG/ADRG, terminology) and chairs technical working groups to drive adoption across CDM,

Qualifications

• Expertise in CDISC standards and regulatory submissions.
• Proven experience maintaining a standards library and governance processes.
• Strong cross-functional collaboration and documentation skills.

Responsibilities

• Own and maintain enterprise CDISC standards across data collection, acquisition, tabulation, and analysis.
• Lead CDISC governance council and chair technical working groups.
• Translate council decisions into actionable standards content and mappings.
• Ensure submission-ready documentation and compliance with 21 CFR Part 11.

Skills

CDISC standards

CDASH/SDTM/ADaM

Define-XML/SDRG/ADRG

Controlled terminology

Data standards governance

Regulatory knowledge (FDA/ICH)

Education

Bachelor's or Master's degree in Life Sciences, CS, or Health Informatics

Tools

EDC/Rave

Regulatory submission tooling

Metadata repository tooling

Job description

Penfield Search Partners Ltd in Connecticut is seeking an Associate Director, Clinical Data Standards and Governance to lead design, implementation, and lifecycle governance of clinical data standards across the enterprise data value chain—from protocol concept and collection through regulatory submission.

This role personally develops and maintains the standards library (CDASH/eCRF, SDTM, ADaM, Define-XML/SDRG/ADRG, terminology) and chairs technical working groups to drive adoption across CDM,