AstraZeneca
Pharmaceuticals
Analyst,ClinicalTrialTransparency,Anonymization
“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
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