Overview

In this role you will lead global oncology study delivery from protocol through close-out, ensuring time, cost and quality targets are met. You will coordinate cross-functional teams and external partners to enable efficient, compliant execution across countries. You will own study documents and participate in meetings to accelerate readiness and inspection readiness. You will ensure supply readiness, manage risks, and oversee budgets and vendor performance. This role offers impact on pivotal cancer trials and collaboration across global teams.

Responsabilidades

Provide oversight of delegated study execution to meet time, cost and quality goals from protocol development through close-out Coordinate interactions with internal functions and external providers (CROs) to enable consistent delivery across countries Lead/contribute to preparation of delegated study documents (e.g., ICF, master Clinical Study Agreement) and external provider materials Plan and facilitate internal and external meetings (Investigators’ and Monitors’ meetings) to align stakeholders Ensure timely supply of investigational product and study materials via Clinical Supply Chain and partners Identify risks and issues, develop mitigations,



drive resolution to maintain momentum Maintain inspection readiness by ensuring study documents are complete and comply with ICH/GCP Support budget management and CRO project oversight to meet timelines and quality Provide project management support to General Study Directors/Associate Directors Operate across multiple countries balancing local and global requirements

Requisitos principales

University degree in a relevant field 3+ years of experience in pharma or academic clinical research environment Knowledge of clinical development and drug development processes across phases and therapy areas Excellent knowledge of ICH/GCP guidelines Strong communication and relationship-building skills, including external service provider management Good project management skills Ability to collaborate and work independently Proficiency with computers and daily tasks Excellent English communication (verbal and written) Excellent communication and relationship-building collaboration and teamwork independence and initiative TMF/eTMF systems EDC and data management interfaces clinical supply planning

📌 Global Study Manager - Late Development Oncology (Barcelona)
🏢 AstraZeneca
📍 Barcelona