Remote Lead Clinical Data Manager — CDISC & EDC Expert

AL Solutions; Poland; On-site; PLN 120,000 - 180,000; Full time

Job summary

AL Solutions is seeking Senior/Lead Clinical Data Managers for an FSP model with a CRO partner, focusing on studies across cross-functional teams. This remote Poland-based role requires leading data management activities, from study start-up to database lock, while ensuring CDISC and ICH-GCP compliance.

The position emphasizes proactive risk management, process improvements, and strong experience with EDC systems (Veeva preferred) in a global trial setting.

Qualifications

• Proven track record working in data management within clinical trials.
• Experience leading studies independently.
• Knowledge of CDISC standards.
• Strong understanding of regulatory requirements and ICH-GCP.
• Hands-on experience with EDC systems (Veeva preferred).

Responsibilities

• Act as the primary data lead within cross-functional study teams.
• Lead study start-up activities by coordinating EDC build & configuration, system integrations, user acceptance testing, and timely completion of data management milestones.
• Manage ongoing data review processes, reconciliation activities, vendor oversight, and database lock readiness to maintain data quality and study timelines.
• Maintain adherence to CDISC standards, ICH-GCP guidelines, and applicable regulatory requirements throughout the clinical trial lifecycle.
• Proactively assess and address project risks while implementing process improvements to enhance operational efficiency and data management quality.

Skills

Data management

Study leadership

CDISC standards

ICH-GCP

EDC systems (Veeva)

Tools

Veeva

Job description

AL Solutions is seeking Senior/Lead Clinical Data Managers for an FSP model with a CRO partner, focusing on studies across cross-functional teams. This remote Poland-based role requires leading data management activities, from study start-up to database lock, while ensuring CDISC and ICH-GCP compliance.

The position emphasizes proactive risk management, process improvements, and strong experience with EDC systems (Veeva preferred) in a global trial setting.