The role is responsible for processing clinical study documents for anonymization to support global regulatory policies like Health Canada's PRCI process and EMA policy 0070
Job Summary
The role is responsible for processing clinical study documents for anonymization to support global regulatory policies like Health Canada's PRCI process and EMA policy 0070.
Candidates must possess a strong understanding of clinical study datasets, documents such as CSRs and SAPs, and the ability to meticulously quality check work delivered.
This individual contributor role requires collaboration with global study teams to deliver submission-ready anonymized documents while adhering to AstraZeneca values and principles.
Matching Summary
The role is responsible for processing clinical study documents for anonymization to support global regulatory policies like 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 in document processing
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