External Data Steward for CDM & Trial Data Quality

Merck; Województwo mazowieckie; In loco; PLN 150.000 - 190.000; Tempo pieno

Descrizione del lavoro

Merck is seeking an External Data Management (EDM) Specialist to support trial-level external-data activities, author transfer specifications, and coordinate ingestion with service providers and IT. The role ensures completeness, reconciliation, traceability, and standardization in data handling.

Responsibilities include gathering data requirements, developing specifications, and performing test/production reviews, while monitoring data loads, validating data for CDM readiness, and contributing

Competenze

• Familiarity with clinical data structures and end-to-end trial data flow.
• Knowledge of CDISC SDTM/CDASH and controlled vocabularies.
• Ability to interpret mapping rules and review load logs.
• Experience with data management in trials and external data handling.

Mansioni

• Gather external data requirements from protocols, service providers and stakeholders.
• Develop external data specifications with stakeholder approvals.
• Execute test and production file reviews for compliance with specifications.
• Monitor external data file loads and resolve issues from logs.
• Support data QC and ensure data are review- and lock-ready for CDM.
• Participate in service provider governance and KPI monitoring.
• Provide updates in team meetings and align with Global Data Management & Standards.

Conoscenze

Clinical development

EDC/CDISC

Data mapping

CDISC standards (SDTM/CDASH)

Communication

Collaboration

Independent work

Risk triage

Formazione

Bachelor's degree

Master's degree or Doctorate

Associate's degree (data management, life sciences, IT)

Strumenti

EDC systems

eCOA

Descrizione del lavoro

Merck is seeking an External Data Management (EDM) Specialist to support trial-level external-data activities, author transfer specifications, and coordinate ingestion with service providers and IT. The role ensures completeness, reconciliation, traceability, and standardization in data handling.

Responsibilities include gathering data requirements, developing specifications, and performing test/production reviews, while monitoring data loads, validating data for CDM readiness, and contributing