Analyst, Clinical Trial Transparency, Redaction

The Clinical Trial Transparency 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 registering the clinical studies on public registries

The CTT Redactions Analyst will process clinical study documents for redaction in support mainly of the EU Clinical Trial Regulation. The individual is accountable to redact submission ready documents to ensure no personal data remains visible and commercially confidential information is protected. 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 what is personal information

• An understanding of what potentially is commercially confidential information

• An understanding of clinical information and essential clinical trial documentation

• The ability to deliver quality output consistently

• A proven track record in delivering against tasks that require attention to detail and focus

• Scientific background is beneficial

• An understanding of clinical study lifecycle and an interest to learn about in the documents created during that lifecycle is beneficial

Typical Accountabilities :

• Create Redacted Clinical Documents following established Redaction Guidelines and SOPs.

• Have knowledge of clinical documents and the clinical study lifecycle.

• 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, best practices in managing confidential business information, 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 and communication with Study teams to secure delivery of redacted documents based on process

• Project opening for new requests 

• Be a system expert in the use of Technology Tool

• Support the delivery of any and all Clinical Trial Transparency activities at AstraZeneca as assigned.

Essential

• Competent verbal and written communication and collaboration skills in English.

• Diligence – attention to detail and ability to manage a programme of concurrent activities.

• Concentration on a task with repeatable delivery needs.

• Understanding of clinical information and basic understanding of clinical trial documentation.

• Ability to understand and adhere to defined guidelines for identification of personal information accurately and demonstrate application across numerous documents.

• BSc computer science, business or life sciences.

Desirable

• Current knowledge of other technical and regulatory requirements relevant to the role.

• Good understanding of Global Medicines Development.

• Basic understanding of what it means to identify something as company confidential information (CCI).

• Adobe Acrobat software experience and understanding.

This role will work globally with individual study teams to deliver redacted documents for regulatory submission. This role will NOT manage the submission; they will provide submission ready deliverables to document authors who will use them for submission needs.  

The role will be an individual contributor.

The successful candidate role models AstraZeneca values and principles and encourages others to do so.