Clinical Trial Transparency Anonymization Analyst

Job title:

Clinical Trial Transparency Anonymization Analyst

Company:

AstraZeneca

Job description

Join our dynamic Clinical Transparency & Data Sharing team within the CMO office at AstraZeneca. We lead the AstraZeneca Group of Companies in Clinical Trial Transparency Position Globally, responsible for clinical data sharing, clinical document sharing and clinical transparency patient engagement activities. As a CTT Anonymization Associate, 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.Accountabilities:
Your role will involve creating anonymized clinical documents following best practices and established SOPs, contributing to the Anonymization Report for the reports created, and becoming a system expert in the use of Technology Tool for delivery of Anonymized Clinical Documents. You will also perform System User Acceptance Testing (UAT) as needed to grow the key tools used to do this job. You will work closely with the Biometrics Data Operations Data De-Identification Team on Risk Measurement and quantification of datasets. You will be accountable for good Information Practice on all assigned activities and maintain a high level of understanding of AstraZeneca policies and guidelines used to deliver to the regulatory policies and support protection of personal information.

• 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.
• 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.
• Support the delivery of any and all Clinical Trial Transparency activities at AstraZeneca as assigned.

Essential Skills/Experience:

• BSc computer science, bioinformatics or life sciences.
• Awareness of database set-up and report publishing requirements.
• Basic understanding of the design of clinical study reports and ICH E3 standards in writing them. Does not have to have authoring experience (a nice to have).
• System Testing experience or desire to learn it.
• Diligence – attention to detail and ability to manage a programme of concurrent activities.
• Concentration on a task with high order of logic and clear thinking when working with fine details across documents.
• 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.

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 exposure of a statistical or database programming language.
• Medical writing experience, turning Tables Figures and Listings into Clinical documents such as Clinical Study Reports (CSRs)
• Understands how programming is used to deliver technical programming and information components of a study.

Are you ready to explore and innovate in our dynamic environment? Be encouraged and supported to think creatively. Here we are free from fear of failure, free to ask the right questions and make bold decisions. It takes resilience to embody our entrepreneurial spirit. For those who thrive on experimentation, you’ll get to work with knowns and unknowns. Exploring without limits. Apply now!At AstraZeneca, we follow the science to explore and innovate. We are unlocking the power of what science can do, working towards treating, preventing, modifying and even curing some of the world’s most complex diseases. We are committed to making a difference, fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. We are always listening and learning from people who live with the diseases our medicines treat. It enables us to better understand their needs and, ultimately, diagnose and design the right treatments to impact patients’ lives. We are harnessing digital, data science & AI to help us achieve the next wave of breakthroughs.Date Posted 01-jul-2024Closing Date 22-jul-2024AstraZeneca 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 candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Expected salary

Location

Barcelona

Job date

Wed, 03 Jul 2024 00:07:02 GMT

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