Senior Analyst, Clinical Trial Transparency Anonymization

2 tygodni temu

Warszawa, Mazovia, Polska AstraZeneca Pełny etat

equire anassociated

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

Competent to advanced verbal and written communication and collaboration skills. Advanced problem solving skills. 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 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. Understands how programming is used to deliver technical programming and information components of a study, including but not limited to the following:Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasetsTables Listings and Figures (TLFs)Clinical Trial Transparency deliverables (data anonymization, results posting files)Awareness of how this data is used to create Clinical Study Reports and other Clinical Documents. 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). BSc in mathematics, statistics, engineering, computer science, bioinformatics or life sciences. System Testing experience or desire to learn it.

Desirable

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)

Date Posted

14-maj-2024

Closing Date

07-cze-2024

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