Associate Director, Clinical Data Standards & Governance

Merck & Co.; North Wales (Montgomery County); Sur place; USD 142 000 - 224 000; Plein temps

Résumé du poste

Merck & Co. is seeking an Associate Director, Data Collection Data Steward for the Global Data Management and Standards (GDMS) within Global Clinical Data Standards (GCDS).

The role oversees program-level data standards, guides study teams on library use, and advances new or modified standards and business processes. You will lead Therapeutic Area Standards Teams (TASTs), train staff, support information governance, track conformance/benefits, and mentor junior staff across the clinical data

Qualifications

• Associate's degree with 15+ years in clinical data management or standards.
• Bachelor's degree with 8+ years in clinical data management or standards.
• Advanced degree (Master/Doctorate) with 4+ years in clinical data management or standards.

Responsabilités

• Define and maintain standardized data collection definitions aligned with CDISC and regulations.
• Lead organizational initiatives and governance efforts (TAST/SLIC).
• Support audits and inspections as required.
• Deliver standards training and mentorship to cross-functional teams.
• Provide governance support for changes to library forms and content.
• Engage in industry forums to influence data standards developments.

Connaissances

CDISC standards

SDTM/CDASH

Data governance

EDC data capture

Regulatory knowledge

Formation

Associate's degree

Bachelor's degree

Master's/Doctorate

Outils

eCRF

SDTM mapping

Define.xml

HL7

Description du poste

Merck & Co. is seeking an Associate Director, Data Collection Data Steward for the Global Data Management and Standards (GDMS) within Global Clinical Data Standards (GCDS).

The role oversees program-level data standards, guides study teams on library use, and advances new or modified standards and business processes. You will lead Therapeutic Area Standards Teams (TASTs), train staff, support information governance, track conformance/benefits, and mentor junior staff across the clinical data