Senior Clinical Data Manager II

hace 1 semana


Barcelona, España AstraZeneca A tiempo completo

Are you ready to coordinate Clinical Data Management deliverables on pivotal clinical studies? As a Senior Clinical Data Manager II, you'll be at the forefront of ensuring the integrity and continuity of our clinical databases. Collaborate with diverse teams and vendors globally to drive studies in line with our innovative models. Whether you're leading less complex studies or acting as a core member of the Global Study Team, your expertise in CDM processes, standards, and technology will be crucial. Dive into a role where your leadership and operational knowledge will shine, all while working under the guidance of a Project Data Manager.AccountabilitiesCoordinate the Clinical Data Management deliverables on assigned studies depending on the relevant model and DM Vendor. Takes accountability and serves as the first line of contact at the study level.Demonstrates leadership 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 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 of day-to-day operational aspects of CDM for assigned studies; Responsible to identify risks and collaborate with the DM Vendor to mitigate the risk. Escalates issues/risks when necessary.Understands corporate, therapeutic/indication or program specific data capture AZ standards.Provide input into CDM related activities associated with regulatory inspections/audits for assigned studies.Responsible for compliance to Trial Master File requirements relating to DM Vendor.Support Senior Leaders to oversee CDM Vendor performance, depending on relevant model. Review, assess and manage DM Vendor delivery against KPIs, budget and overall performance. Oversees vendor timelines and milestone deliverables for the assigned studies. Ensures DM Vendor billing is accurate and gives recommendations for



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