Senior External Data Management Lead (Trial Data)

MSD; Województwo mazowieckie; In loco; PLN 180.000 - 280.000; Tempo pieno

Descrizione del lavoro

MSD is seeking an External Data Management Senior Specialist in Poland to lead trial-level external data strategy and delivery studies. The role owns transfer-spec development, monitors data transfers, and drives defect triage and data readiness in compliance with SOPs and ICH‑GCP.

Mentors junior analysts and reports metrics and lessons learned. The candidate will support the CDM Trial Lead in data quality oversight, collaborate with cross-functional teams, and lead service provider governance,

Competenze

• 8+ years experience in data management, clinical trial operations, or related field.
• Associate's Degree with 7+ years in data management or related field.
• Bachelor's Degree with 5+ years in data management or related field.
• Advanced Degree (Masters/Doctorate) in related disciplines preferred.

Mansioni

• Gather external data requirements from protocols, service providers, and study teams.
• Verify external data specifications are developed, compliant with standards, and approved by stakeholders.
• Oversee external data file loading, review error logs, and drive resolution of data load issues.
• Mentor junior analysts on tools, checks, and service provider interactions.
• Lead trial-level service provider management activities, including performance trending and issue/risk reviews.
• Maintain compliance with SOPs, ICH-GCP, and protocol-specific processes.

Conoscenze

Communication

Mentorship

Stakeholder management

Decision making

Project leadership

Status reporting

Formazione

Bachelor's Degree in Life Sciences / IT / Data

Associate's Degree with 7+ years experience in data management

Advanced Degree (Masters/Doctorate) in related disciplines

Strumenti

EDC platforms

External data integrations

Descrizione del lavoro

MSD is seeking an External Data Management Senior Specialist in Poland to lead trial-level external data strategy and delivery studies. The role owns transfer-spec development, monitors data transfers, and drives defect triage and data readiness in compliance with SOPs and ICH‑GCP.

Mentors junior analysts and reports metrics and lessons learned. The candidate will support the CDM Trial Lead in data quality oversight, collaborate with cross-functional teams, and lead service provider governance,