Senior External Data Strategy Lead

Caraway Therapeutics, Inc.; Województwo mazowieckie; In loco; PLN 180.000 - 300.000; Tempo pieno

Descrizione del lavoro

Merck & Co., Inc. in Poland seeks an External Data Management Senior Specialist to lead trial-level external data strategy and delivery. You will own transfer-spec development, oversee data quality, and mentor junior analysts while coordinating with GDMS, IT, and study teams.

You will ensure SOP/ICH-GCP compliance, manage data readiness for database lock, and drive improvements in data reconciliation and risk management across trials.

Competenze

• Experience in Clinical Data Management within trials and data governance.
• Ability to prepare audit-ready documentation with attention to compliance.
• Excellent communication with cross-functional teams and external partners.
• Deep understanding of EDC platforms and external data integration workflows.

Mansioni

• Gather external data requirements from protocols, service providers, and study teams.
• Ensure external data specifications are developed, compliant with standards and approved by required stakeholders.
• Verify that test and first production files conform to approved external data specifications.
• Oversee external data file loading, review error logs, and drive resolution of data load issues.
• Proactively support the CDM Trial Lead in trial-level data quality oversight and risk identification.
• Lead trial-level service provider management activities, including performance trending and issue/risk reviews.
• Maintain compliance with SOPs, ICH-GCP, and protocol-specific processes.
• Archive required documentation to ensure traceability and inspection readiness.

Conoscenze

Clinical Data Management

Data Management

English Language

Stakeholder Management

Vendor Management

Formazione

Bachelor's Degree in Life Sciences or Data Science

Associate's Degree with 7+ years experience

Master's Degree in related field

Advanced Degree (PhD) in related field

Descrizione del lavoro

Merck & Co., Inc. in Poland seeks an External Data Management Senior Specialist to lead trial-level external data strategy and delivery. You will own transfer-spec development, oversee data quality, and mentor junior analysts while coordinating with GDMS, IT, and study teams.

You will ensure SOP/ICH-GCP compliance, manage data readiness for database lock, and drive improvements in data reconciliation and risk management across trials.