Study Data Management Director (CDM Lead)

AstraZeneca GmbH; Barcelona; Presencial; EUR 70.000 - 95.000; Jornada completa

Descripción de la vacante

AstraZeneca GmbH is seeking an experienced Clinical Data Management professional to coordinate CDM deliverables across assigned studies, acting as the main DM contact for vendors. You will lead DM activities, ensure data quality and compliance with GCDMP and regulatory requirements, and support inspections and process improvements.

The role requires strong project management, the ability to work with external partners, and extensive experience with EDC/CDMS and database design.

Formación

• University or college degree in life sciences or related field.
• Solid knowledge of Clinical Data Management in Biotech/Pharma/CRO.
• Demonstrated understanding of Good Clinical Data Management Practices (GCDMP) and regulatory requirements.
• Strong Project Management and Lead DM experience; metrics analysis & reporting.
• Demonstrated ability to work effectively with external partners.
• Experience with clinical databases, various CDMS and EDC systems.

Responsabilidades

• Coordinate the Clinical Data Management deliverables on assigned studies; main DM contact for the vendor.
• Provide leadership and mentorship to DM team members and oversee DM activities.
• Ensure CDM deliverables meet AZ standards and data quality requirements.
• Support regulatory inspections/audits and lead DM inspection readiness.
• Manage DM vendor performance, KPIs, budget, timelines, and invoicing.
• Maintain DM processes and TMF compliance; participate in continuous improvement.

Descripción del empleo

AstraZeneca GmbH is seeking an experienced Clinical Data Management professional to coordinate CDM deliverables across assigned studies, acting as the main DM contact for vendors. You will lead DM activities, ensure data quality and compliance with GCDMP and regulatory requirements, and support inspections and process improvements.

The role requires strong project management, the ability to work with external partners, and extensive experience with EDC/CDMS and database design.