Clinical Trial Transparency Anonymization Associate
- Experience Level
- Experienced (non-manager)
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 Associate 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.
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 AstraZeneca policies and guidelines used to delivery to the 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.
Education, Qualifications, Skills and Experience
- Competent verbal and written communication and collaboration skills.
- Successful 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 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.
- 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 computer science, bioinformatics or a technical life science.
- 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 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, 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.