Global Study Manager - Cell Therapy

Introduction to role:
This role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English is required.

Are you ready to orchestrate complex, global clinical studies that bring next‑generation cancer therapies to patients faster? As a Global Study Manager within Cell Therapy Clinical Operations (CTCO), you will sit at the center of high-impact study teams , translating protocol into real-world execution and keeping delivery on time, on budget and to the highest quality standards. You will drive end-to-end study delivery from protocol development through start-up, maintenance, close-out, CSR and archiving.

Working across countries and functions, you will align internal experts and external partners, anticipate risks, and keep studies inspection-ready at all times. Do you thrive when you can make bold, evidence-based decisions, constructively challenge, and mobilize CROs, sites, data, supply and quality stakeholders to solve issues before they impact patients?

Accountabilities:

In partnership with AZ enablement team, other AZ clinical experts and external service providers, the GSM provides oversight to ensure study delivery.

Leads/contributes to the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc.).Maintains and facilitates interactions with internal functions including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives.

Contributes to the planning and conduct of internal and external meetings (e.g. Investigators’/Monitors’ meeting).Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate.

Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.

Ensures that all study documents in scope of GSM’s responsibilities are complete and verified for quality in Trial Master File.

Supports GSD/GSAD with budget management, such as external service provider invoice reconciliation.

Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times.

Supports GSD/ GSADs in project management as per agreed delegation.

For outsourced studies, supports GSD/GSAD in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant AZ SOPs and guidelines (e.g. description of services and transfer of obligations).Take

on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Essential Skills/

Experience:

University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years. Knowledge of clinical development / drug development process in various phases of development and therapy areas. Excellent knowledge of international guidelines ICH/GCP. Excellent communication and relationship building…