Electronic trial master file (etmf) setup and maintenance
Collection of regulatory and essential documents
Clinical-regulatory document creation and management
Support Global Study Leaders and Managers by completing delegated study work and leading the set-up, maintenance, and closure of the electronic Trial Master File (eTMF) to ensure compliance
Job Summary
Support Global Study Leaders and Managers by completing delegated study work and leading the set-up, maintenance, and closure of the electronic Trial Master File (eTMF) to ensure compliance.
Collaborate with internal staff and external vendors to collect essential documents, contribute to electronic submissions, and manage study documents according to technical standards.
Coordinate administrative tasks, logistic support, and practical arrangements for meetings, while also contributing to process improvements and leading improvement projects.
Matching Summary
Support Global Study Leaders and Managers by completing delegated study work and leading the set-up, maintenance, and closure of the electronic Trial Master File (eTMF) to ensure compliance.
Skills & Requirements
Must-have
Electronic Trial Master File (eTMF) setup and maintenance
Collection of regulatory and essential documents
Clinical-regulatory document creation and management
Study document production and compliance
AstraZeneca tracking and communication tools
Clinical Trial Transparency (CTT) support
Nice-to-have
Professionalism and mutual respect
Willingness to train others
Harnessing industry-leading skills
Inclusive and diverse team environment
Key Requirements
Education in medical or biological sciences preferred
Proven organizational and analytical skills
Previous administrative training/experience
Computer proficiency in day-to-day tasks
Working knowledge of Clinical Study Process and ICH/GCP guidelines
Excellent verbal and written communication in English