Global Study Associate

hace 1 semana


Barcelona, 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 setup, 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.
  • Setup, 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 studyrelated 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 12 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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