Global Study Associate

hace 5 meses

Barcelona, España AstraZeneca A tiempo completo

**Disability certification of 33% / Certificado de Discapacidad 33%***

**Location**:Barcelona, Spain

The Global Study Associate is responsible for supporting the delivery of clinical studies by providing administrative and system support. The Global Study Associate will work across several studies, so a high degree of flexibility is required. The exact accountabilities will differ depending on the exact nature of the clinical program.

**Typical Accountabilities**
- Collect, review and track relevant study documents.
- Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF). Coordinate regular Quality Checks (QC) and review of the TMF, ensuring continual inspection readiness.
- Support production of study documents, ensuring template and version compliance and that relevant documents are ready for publishing in the regulatory document management system.
- Set-up, populate and accurately maintain information in tracking systems and communication tools. Support other study team members in the use of these systems.
- Manage and contribute to the coordination and tracking of study materials and equipment.
- Assist in the tracking and reconciliation of invoices.
- Support study team and provide study metrics / reports during the study, audits and regulatory inspections.
- Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, investigator meetings and advisory boards.
- Liaise with internal and external participants and/or vendors. Track approvals and completion of required documents.
- Prepare and distribute study-related correspondence. Contribute to and distribute material for meetings, newsletters and websites.

**Education, Qualifications, Skills and Experience**
- University degree / Batchelor’s degree, or equivalent experience.
- Good understanding of drug development.
- Minimum of 1-2 years’ experience of administrative / operational support of clinical studies.
- United States only: Bachelor's Degree and 1+ years of experience, Associate's degree plus 6+ years of experience or High School plus 10+ years of experience.
- Knowledge of ICH-GCP principles.
- Team orientated.
- Ability to coordinate and prioritise multiple tasks and deliverables.
- Proactive approach.
- High degree of flexibility.
- Demonstrated verbal and written communication skills.

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