External Data Management & CDM Specialist

MSD; Warszawa; Hybrid; PLN 180.000 - 300.000; Vollzeit

Zusammenfassung

Merck & Co., Inc. Warsaw is seeking an External Data Management Specialist to support trial-level external-data activities, author transfer specifications, and coordinate with service providers/IT for accurate data ingestion.

You will ensure completeness, reconciliation, traceability, and audit readiness under CDM standards. You will engage with GDMS and cross-functional teams, monitor KPIs, and contribute to continuous improvement initiatives, including archiving documentation in the eTMF per

Qualifikationen

• 4+ years of experience in data management, clinical trial operations, or a related field.
• Associate’s/Bachelor’s/Master’s with relevant experience options stated in job posting.
• Knowledge of ICH-GCP compliance and SOP-driven environments.

Aufgaben

• Gather external data requirements from protocols, service providers, and study stakeholders.
• Develop external data specifications with stakeholder approvals.
• Execute test and production file reviews to ensure adherence to specifications.
• Monitor external data file loads and resolve issues or escalate as needed.
• Support CDM data quality oversight and risk identification.
• Archive and maintain external data documentation in eTMF per SOPs.

Kenntnisse

Clinical data understanding

EDC data handling

CDISC standards (SDTM/CDASH)

LOINC vocabularies

Data reconciliation

Ausbildung

Bachelor’s degree in Life Sciences

Master’s/Doctorate in Nursing/Pharmacy/Life Sciences/IT

Associate’s degree + 3+ years experience

Tools

EDC systems

eCOA tools

Data extraction tools

Jobbeschreibung

Merck & Co., Inc. Warsaw is seeking an External Data Management Specialist to support trial-level external-data activities, author transfer specifications, and coordinate with service providers/IT for accurate data ingestion.

You will ensure completeness, reconciliation, traceability, and audit readiness under CDM standards. You will engage with GDMS and cross-functional teams, monitor KPIs, and contribute to continuous improvement initiatives, including archiving documentation in the eTMF per