Clinical Trial Transparency Analyst - Remote

Overview

The Clinical Trial Transparency Analyst will be responsible for processing clinical study documents for anonymization and ensuring compliance with regulatory policies while working in a hybrid model from Warsaw, Poland.

In Short

• Process clinical study documents for anonymization and pseudo-anonymization.
• Work with global study teams to deliver anonymized documents.
• Ensure compliance with Health Canada’s PRCI process and EMA policy 0070.
• Maintain high attention to detail and quality in deliverables.
• Utilize the latest technology and tools for document anonymization.
• Support development of training materials as needed.
• Contribute to the Anonymization Report.
• Perform User Acceptance Testing (UAT) for key tools.
• Collaborate with Biometrics Data Operations on data de-identification.
• Adhere to AstraZeneca policies and guidelines.

Requirements

• BSc in computer science, bioinformatics, or a technical life science.
• Understanding of clinical study datasets and documents.
• Proven analytical and problem-solving skills.
• Experience in system testing is a plus.
• Knowledge of data risk management related to clinical studies.
• Strong verbal and written communication skills.
• Attention to detail and ability to manage concurrent activities.
• Awareness of clinical study report design and ICH E3 standards.
• Prior experience with statistical or database programming languages is desirable.
• Medical writing experience is a plus.

Benefits

• Opportunity to work in a global, science-led biopharmaceutical company.
• Inclusive and diverse working environment.
• Focus on lifelong learning and development.
• Empowerment to challenge conventional thinking.
• Work that has the potential to change lives.