Global Study Associate

hace 6 días

Barcelona, España AstraZeneca A tiempo completo

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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