Senior External Data Strategy & Quality Lead

Merck; Województwo mazowieckie; In loco; PLN 180.000 - 260.000; Tempo pieno

Descrizione del lavoro

Merck is seeking an External Data Management Senior Specialist to lead trial-level external data strategy and delivery. The role owns transfer-spec development, monitors transfers, drives defect triage, ensures regulatory compliance, and mentors junior analysts.

You will report metrics and help GPDM quality oversight and risk identification. You will collaborate with GDMS, IT, and cross-functional teams to close feedback loops, escalate high-impact risks, and ensure data readiness for database

Competenze

• Experience leading external data strategy for trials in CDM.
• Proven ability to author external data specifications and data transfers.
• Knowledge of ICH-GCP, SOPs and clinical trial data flow.
• Strong documentation, audit readiness, and issue resolution skills.

Mansioni

• Gather external data requirements from protocols, providers, and study teams.
• Develop external data specifications and obtain stakeholder approvals.
• Verify test and production files meet external data specs.
• Oversee external data file loading and resolve data load issues.
• Support data quality oversight and risk identification for trials.
• Lead reconciliation and validation activities for data usability.
• Lead service provider forums and monitor KPIs/SLAs.
• Present performance metrics to management and governance forums.
• Support QA activities related to provider qualification and CAPA.
• Collaborate with GDMS, IT and cross-functional teams to align priorities.
• Troubleshoot platform or integration issues with IT and escalate risks.
• Mentor junior analysts on tools, checks, and provider interactions.
• Lead trial-level service provider management and trend analysis.
• Contribute to continuous improvement in processes and standards.
• Maintain SOPs compliance and archive documents in eTMF for traceability.

Conoscenze

External data management

CDM processes

EDC platforms

Data governance

Stakeholder communication

Data quality oversight

Descrizione del lavoro

Merck is seeking an External Data Management Senior Specialist to lead trial-level external data strategy and delivery. The role owns transfer-spec development, monitors transfers, drives defect triage, ensures regulatory compliance, and mentors junior analysts.

You will report metrics and help GPDM quality oversight and risk identification. You will collaborate with GDMS, IT, and cross-functional teams to close feedback loops, escalate high-impact risks, and ensure data readiness for database