AstraZeneca
Pharmaceuticals
Analyst,ClinicalTrialTransparency,Anonymization
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Analyst, Clinical Trial Transparency, Anonymization at AstraZeneca. Skills: Anonymization, Clinical Documents, Data Privacy. Process clinical study documents for anonymization. Anonymize submission clinical study documents”
What You'll Achieve.
deliver anonymized documents for regulatory submission; provide submission ready deliverables to regulatory submission teams
Industry & Context.
Successful problem-solving skills; analytical and reviewing skills
What They're Looking For.
Must Have
Competent verbal and written communication and collaboration skills, Successful problem-solving skills, Diligence – attention to detail, Concentration on a task with high order of logic, Ability to understand and adhere to defined business processes, Understands how data risk management is used, Awareness of database set-up and report publishing requirements, Basic understanding of the design of clinical study reports, BSc in computer science, bioinformatics or a technical life science, System Testing experience or desire to learn it
Nice to Have
Current knowledge of other technical and regulatory requirements, 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, Understands how programming is used to deliver technical programming and information components of a study, Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets, Tables Listings and Figures (TLFs), Clinical Trial Transparency deliverables, Awareness of how this data is used to create Clinical Study Reports
What You'll Do.
Process clinical study documents for anonymization
Anonymize submission clinical study documents
Create Anonymized Clinical Documents
Contribute to the Anonymization Report
Perform System User Acceptance Testing (UAT)
Understands the data collected
Work closely with the Biometrics Data Operations Data De-Identification Team
Accountable for good Information Practice
Maintain high level of understanding of AstraZeneca policies
Support development of any training materials
Ensures adherence to all applicable AstraZeneca requirements
Demonstrates a high focus on quality
Work with a continuous improvement mindset
Support the delivery of any and all Clinical Trial Transparency activities
How You'll Work.
Team & Collaboration
Work closely with the Biometrics Data Operations Data De-Identification Team; Support development of any training materials as needed in collaboration with direct manager
Communication Scope
Competent verbal and written communication; collaboration skills
Process & Methodology
manage a programme of concurrent activities
Full Job Description
**Location:** Warsaw, Poland **Hybrid model of work:** 3 days in office, 2 remote per week The Clinical Transparency & Data Sharing team is within CMO office and leads 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 such as the Lay Summaries and Thank you cards. The **CTT Anonymization Analyst** 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. The individual is accountable to anonymize submission clinical study documents and associated study data using the latest tools and industry best practices. This role will require an in-depth understanding of how AstraZeneca works to meet associated regulatory policies, privacy, clinical data and documents. The ideal candidate possesses the following: * An understanding of clinical study datasets, clinical documents (CSR, CSP, SAP) and outputs (TLFs) * An understanding of the data used to create Clinical Study Reports (CSRs) * expertise in using systems and an interest in using the latest technology to achieve challenging tasks * proven track record for attention to detail * strong analytical and reviewing skills * proven track record in delivering against tasks that require attention to detail and focus * scientific background is beneficial * understanding how SAS programming language is used to deliver clinical study datasets is an advantage This role will work globally with individual study teams to deliver anonymized documents for regulatory submission and data sharing. This role will NOT manage the submission; they will provide submission ready deliverables to regulatory submission teams. The role will be an individual contributor. The successful candidate role models AstraZeneca
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