The role is responsible for processing clinical study documents for anonymization in support of Health Canada's PRCI process and EMA policy 0070
Job Summary
The role is responsible for processing clinical study documents for anonymization in support of Health Canada's PRCI process and EMA policy 0070.
Candidates must possess an in-depth understanding of AstraZeneca's regulatory policies, privacy standards, and clinical data lifecycle.
This individual contributor position requires meticulous quality checking and collaboration with global study teams to deliver submission-ready anonymized documents.
Matching Summary
The role is responsible for processing clinical study documents for anonymization in support of Health Canada's PRCI process and EMA policy 0070.
Skills & Requirements
Must-have
Understanding of clinical study datasets
Knowledge of Clinical Study Reports (CSRs)
Attention to detail and analytical skills
Adherence to privacy and regulatory policies
Experience with system user acceptance testing
Nice-to-have
Scientific background preferred
SAS programming language knowledge
Medical writing experience
Continuous improvement mindset
Global medicines development awareness
Key Requirements
BSc in computer science, bioinformatics or technical life science