Overview
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In this role you drive and coordinate Clinical Data Management deliverables across assigned studies, ensuring data quality and adherence to AZ standards. As a key liaison to DM vendors, you guide study-level CDM activities and manage vendor performance and timelines. You contribute to regulatory readiness and continuous improvement of DM processes within a integral, cross-functional team. This position offers impact on data integrity, inspection readiness, and scalable DM operation models in a leading biotech/pharma environment.
Responsabilidades
Coordinate CDM deliverables across studies and DM models, acting as the study-level contact
Provide leadership and project management for CDM deliverables, potentially mentored by a Project Data Manager
Serve as primary DM vendor contact and guide Lead Data Manager/DM Team Lead
Identify and mitigate DM risks with vendors; escalate as needed
Contribute to corporate and program data capture standards (AZ), ensuring data quality and consistency
Drive compliance with DM standards for data capture and quality
Input to DM activities for regulatory inspections/audits and lead inspection preparation




Support vendor selection and use of software systems, devices, and vendors
Ensure Trial Master File compliance for relevant DM models and vendors
Monitor DM vendor performance, KPIs, budgets, billing, and timelines; support payments decisions
Engage in change initiatives and continuous improvement of DM operating models
Mentor junior Clinical Data Management staff
Requisitos principales
University or college degree in life sciences, pharmacy, nursing or equivalent
Solid knowledge of Clinical Data Management in biotech/pharma/CRO
Strong understanding of GCDMP and regulatory requirements
Proven xqbhyrx project management and lead DM experience with metrics/reporting expertise
Ability to collaborate with external partners
Experience with clinical databases, DM systems and EDC
Understanding of query management and reconciliation processes
Excellent written and verbal communication; strong problem-solving skills
Ability to work independently and in a global team
Excellent organizational and analytical skills with attention to detail
communication
problem solving
team collaboration
EDC (electronic data capture)
clinical databases
data standards (CDISC)

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