Global Study Manager - Cell Therapy

About the role

AstraZeneca is looking for a Global Study Manager within Cell Therapy Clinical Operations (CTCO) in Barcelona, with an on-site commitment of three days a week and fluency in English required. The role sits at the centre of high-impact study teams, driving end-to-end delivery of complex global clinical studies from protocol development through start-up, maintenance, close-out, CSR and archiving, while keeping studies inspection-ready.

Key responsibilities

• In partnership with the AZ enablement team, other AZ clinical experts and external service providers, provide oversight to ensure study delivery.
• Lead or contribute to the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement) and external service provider documents (specifications, procedures, presentations).
• Maintain and facilitate interactions with internal functions (Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance) and external partners (CROs) to meet time, cost and quality objectives.
• Contribute to the planning and conduct of internal and external meetings such as Investigators' and Monitors' meetings.
• Ensure the supply of investigational product and study materials by liaising with Clinical Supply Chain or external providers.
• Proactively identify risks and issues and develop mitigation or action plans.
• Ensure study documents in scope are complete and verified for quality in the Trial Master File.
• Support GSD/GSAD with budget management, including external service provider invoice reconciliation, and adhere to global clinical processes, quality and compliance manuals and ICH/GCP.
• Support GSD/GSAD in project management and, for outsourced studies, manage the CRO Project Manager's oversight in line with AZ SOPs.
• Take on assignments on non-drug project work such as process improvements as agreed with the manager.

Required profile

• University degree (or equivalent), preferably in medical or biological sciences or a discipline associated with clinical research.
• Relevant experience in the pharmaceutical industry or a similar organisation, or academic experience, preferably at least 3 years.
• Knowledge of the clinical development/drug development process across phases and therapy areas.
• Excellent knowledge of ICH/GCP and excellent English, verbal and written.
• Desirable: advanced degree, experience across all phases of a clinical study lifecycle, basic knowledge of GMP/GLP.

Required skills

• Excellent communication and relationship-building skills, including managing external service providers.
• Good project management skills.
• Ability to collaborate and work independently, with demonstrated leadership.
• Advanced computer skills for day-to-day tasks.