Responsible to coordinate the Clinical Data Management (CDM) deliverables on assigned clinical studies and may be an expert on CDM processes, standards, and technology. Member of the Integral Study Team (GST) and the main point of contact for the Data Management (DM) vendor. Responsible to ensure CDM deliverables follow standards and meet data quality. Maintains business continuity for CDM processes and standards including integrity of the clinical database for the relevant studies. May work under direction of a Project Data Manager.

Typical Accountabilities

• Coordinate the Clinical Data Management deliverables on assigned studies depending on the relevant DM model and DM Vendor. Takes accountability and serves as the first line of contact at the study level.
• Demonstrates strong leadership, project management skills and operational knowledge in the planning and delivery of CDM deliverables at a study level, potentially under mentorship from a Project Data Manager.
• Communicates and collaborates effectively with all study level team members.



Primary point of contact for DM vendor and provides guidance and supervision to Lead Data Manager/DM Team Lead working on the study (CRO or in-house).
• Oversight and expertise input into the day-to-day operational aspects of DM for assigned studies; Responsible to identify risks and collaborate with the DM Vendor to mitigate the risks. Escalates issues/risks as necessary.
• High level understanding and contribution to corporate, therapeutic/indication and program specific data capture AZ standards.
• Drive adherence to AZ DM standards and processes for data quality and consistency of data capturing for assigned studies.
• Provide input into DM related activities associated with regulatory inspections/audits for assigned studies. Lead DM inspection preparation for assigned studies.
• May provide input to the selection and use of software systems, devices, and vendors.
• Responsible for compliance to Trial Master File requirem

📌 Associate Director Study Data Manager (Barcelona)
🏢 AstraZeneca
📍 Barcelona