Senior Analyst, Clinical Trial Transparency Anonymization
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 associated regulatory policies, privacy, clinical data and documents. The ideal candidate possesses the following:
- Strong understanding of clinical study datasets, clinical documents (CSR, CSP, SAP) and outputs (TLFs)
- Experience working with data 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
- Stay focused and heedful in delivery of assigned tasks
- Proven track record for looking at innovative ways to solve problems
- Scientific background is beneficial
- Understanding SAS programming language and or clinical data sets 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.
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.
- 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) datasets
- Tables 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.
- 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 candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.