Electronic trial master file (etmf) setup and maintenance
Ich/gcp guidelines compliance knowledge
Astrazeneca tracking tools proficiency
The role involves supporting Global Study Leaders by initiating and maintaining the electronic Trial Master File to ensure ICH/GCP compliance
Job Summary
The role involves supporting Global Study Leaders by initiating and maintaining the electronic Trial Master File to ensure ICH/GCP compliance.
Candidates will collaborate with internal staff and external vendors to collect regulatory documents and manage clinical-regulatory submissions via ANGEL.
The position requires coordinating study materials, logistics, and administrative tasks while utilizing AstraZeneca's specific tracking and communication tools.
Matching Summary
The role involves supporting Global Study Leaders by initiating and maintaining the electronic Trial Master File to ensure ICH/GCP compliance.
Skills & Requirements
Must-have
Electronic Trial Master File (eTMF) setup and maintenance
ICH/GCP guidelines compliance knowledge
AstraZeneca tracking tools proficiency
Regulatory document submission experience
Study budget tracking and reconciliation
Nice-to-have
Ability to work independently in team environment
Experience with process improvement projects
Willingness to train others on procedures
Excellent verbal and written communication skills
Proficiency in presentation material creation
Key Requirements
Education in medical or biological sciences preferred
Previous administrative training or experience required
Working knowledge of Clinical Study Process and ICH/GCP