Experteer Overview

¿Quiere enviar su solicitud? Lea toda la información sobre este puesto a continuación y luego pulse el botón de solicitar.

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.

Compensaciones / Beneficios

- 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

Responsabilidades

- University or college degree in life sciences, pharmacy, nursing or equivalent
- Solid knowledge of Clinical Data Management in biotech/pharma/CRO xugodme
- 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

Requisitos principales

•

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