Overview

As Global Study Manager in CTCO, you drive end-to-end study delivery for cell therapy programs from protocol to close-out. You will coordinate cross-functional teams and external partners to meet time, cost, and quality targets while ensuring inspection readiness. The role sits at the center of high-impact studies, enabling execution across countries and functions. You will address risks proactively and support improvements in study processes. This is a fast-paced opportunity to shape integral oncology trials and deliver transformative therapies to patients.

Responsabilidades

Oversee study delivery in partnership with enablement teams and external service providers Lead preparation of delegated study documents (e.g., ICF, master CTAs) and related external service provider documents Coordinate with internal functions (Enablement, Data Management, Procurement, Regulatory, Patient Safety, QA) and CROs to ensure timely, budget-conscious,



quality-focused delivery Plan and conduct internal and external meetings with investigators and monitors Ensure supply of Investigational Product and study materials via Clinical Supply Chain or external partners Identify risks and issues and develop mitigation/action plans Verify study documents are complete and QA-ready in the Trial Master File Support budget management and external vendor invoice reconciliation Adhere to global clinical processes, SOPs, and ICH/GCP guidelines to maintain inspection readiness Support project management for GSD/GSADs per delegation and oversee CRO Project Manager for outsourced studies

Requisitos principales

University degree in medical or biological sciences or related clinical research field At least 3 years experience in pharmaceutical or equivalent organization Knowledge of clinical development processes across phases and therapy areas Excellent knowledge of ICH/GCP Strong communication and relationship-building skills, including external partner management Good project management skills and ability to collaborate as well as work independently Demonstrated leadership Advanced computer skills and fluent English (spoken and written) communication skills relationship building leadership ICH/GCP knowledge project management external vendor management

📌 Global Study Manager - Cell Therapy (Barcelona)
🏢 AstraZeneca
📍 Barcelona