Senior Clinical Trial Transparency Anonymization Analyst

Join our Clinical Transparency & Data Sharing team within the CMO office, leading the AstraZeneca Group of Companies' Clinical Trial Transparency Position Globally. We are responsible for clinical data sharing, clinical document sharing, and clinical transparency patient engagement activities. As a Clinical Trial Transparency Anonymization Analyst, you will process clinical study documents for anonymization and/or pseudo anonymization in support of Health Canada’s PRCI process, EMA policy 0070, and other disclosure of clinical documents that must be redacted or otherwise anonymized. 

Typical Accountabilities and required competencies

• Create Anonymized Clinical Documents following best practices and established SOPs.
• Contribute to the Anonymization Report for the reports created.
• Be a system expert in the use of Technology Tool for delivery of Anonymized Clinical Documents.
• Perform System User Acceptance Testing (UAT) as needed to grow the key tools used to do this job.
• Understands the data collected and used in the Clinical Study lifecycle from site through to Clinical Document authoring.
• Work closely with the Biometrics Data Operations Data De-Identification Team on Risk Measurement and quantification of datasets.
• Accountable for good Information Practice on all assigned activities
• Maintain high level of understanding of regulatory policies and support protection of personal information
• Support development of any training materials as needed in collaboration with direct manager.
• Ensures adherence to all applicable AstraZeneca requirements, including but not limited to clinical operations, quality, and data privacy.
• Demonstrates a high focus on quality and the ability to meticulously quality check work delivered.
• Work with a continuous improvement mindset, looking for opportunities to improve the process and increase delivery efficiencies as this capability grows.
• Support the delivery of any and all Clinical Trial Transparency activities at AstraZeneca as assigned.

Essential Skills/Experience:
- BSc in mathematics, statistics, engineering, computer science, bioinformatics or life sciences.
- Ability to apply programming knowledge and skills to problems, problem-solving, and quality focus under supervision.
- Ability to understand and adhere to defined business processes and accurately complete and manage associated documentation.
- Understands how data risk management is used to support anonymizing clinical study data and reports.
- Awareness of database set-up and report publishing requirements.
- Relevant SAS programming knowledge and experience to a proficient level for risk measurement.
- Basic understanding of the design of clinical study reports and ICH E3 standards in writing them.
- System Testing experience or desire to learn it.

Desirable Skills/Experience:
- Current knowledge of other technical and regulatory requirements relevant to the role.
- Good understanding of Global Medicines Development
- Knowledge of Best practices in Validated systems delivery
- Prior relevant knowledge of a statistical or database programming language (preferably SAS).
- Medical writing experience, turning Tables Figures and Listings into Clinical documents such as Clinical Study Reports (CSRs)

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified c