Overview 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 general, 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 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