11 ago
|
AstraZeneca
|
España
11 ago
AstraZeneca
España
Experteer Overview
In this role you will support the delivery of clinical studies within Bio
Pharmaceuticals Clinical Operations, Study Management, from CSP development through study close-out and archival.
You will work cross-functionally with internal teams and external partners to oversee study delivery to time, cost and quality.
You will influence study documents, risk mitigation, budgets, and supplier oversight to ensure inspection readiness and successful study outcomes.
This is a chance to shape how integral studies are executed in a large, diverse organization.
Compensaciones / Beneficios
• Oversee study delivery in partnership with AZ teams and external providers
• Lead or contribute to preparation of delegated study documents and vendor-related materials
• Coordinate interactions with internal and external functions including CROs to ensure efficient delivery
• Plan and conduct internal/external meetings (Investigators’/Monitors’ meetings)
• Ensure supply of investigational products and study materials via Clinical Supply Chain or providers
• Identify risks/issues and develop mitigation/action plans
• Verify study documents are complete and quality-checked in the Trial Master File
• Support GSD/GSAD with budget management and invoice reconciliation
• Ensure compliance with ICH/GCP and AZ SOPs for inspection readiness
• Assist with overall project management per delegation
• For outsourced studies, manage CRO PMs to meet timelines, budget and quality with proper oversight
• Take on non-drug project work related to process improvements as agreed with manager
Responsabilidades
• University degree (or equivalent)
• 3+ years of relevant experience in pharma or academia
• Knowledge of clinical development processes across study phases
• Excellent knowledge of ICH/GCP
• Excellent communication and relationship-building skills, including external vendor management
• Good project management skills
• Demonstrated ability to collaborate and work independently
• Demonstrated leadership skills
• Computer proficiency and English communication skills
Requisitos principales
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📌 Global Study Manager (España)
🏢 AstraZeneca
📍 España