Trial Data Transfer & CDM Specialist

MSD; Województwo mazowieckie; On-site; PLN 120,000 - 180,000; Full time

Job summary

MSD is seeking an External Data Management (EDM) Specialist to support trial-level external-data activities, author and maintain transfer specifications, and coordinate with service providers/IT for accurate ingestion. You will ensure data completeness, reconciliation, traceability, and compliance with ICH‑GCP.

The role emphasizes collaboration with GDMS and cross‑functional teams to drive quality and timely delivery.

Qualifications

• 4+ years of experience in data management, clinical trial operations, or a related field.
• Experience with trial data standards and data quality processes.
• Ability to interpret mapping rules and review load logs.
• Experience supporting audits and CAPA activities.

Responsibilities

• Gather external data requirements from protocols, service providers, and study stakeholders.
• Develop external data specifications in accordance with standards, obtaining required stakeholder approvals.
• Execute test and first-production file reviews to confirm adherence to approved external data specifications.
• Monitor external data file loads, review error logs, and resolve or escalate issues.

Skills

Clinical data management

Data quality assurance

Stakeholder communication

Audit readiness

Education

Bachelor's degree in Life Sciences or IT

Master's degree preferred

Tools

EDC systems

eCOA

CDISC SDTM

Clinical data standards

Job description

MSD is seeking an External Data Management (EDM) Specialist to support trial-level external-data activities, author and maintain transfer specifications, and coordinate with service providers/IT for accurate ingestion. You will ensure data completeness, reconciliation, traceability, and compliance with ICH‑GCP.

The role emphasizes collaboration with GDMS and cross‑functional teams to drive quality and timely delivery.