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AstraZeneca·Pharma·7 hours ago

Analyst, Clinical Trial Transparency, Redaction (12 months fixed-term)

Warsaw, PolandTemporaryMid · 2-5 yearsH1B likely

About this role

Location: Warsaw

Model: hybrid 3+2

The Clinical Trial Transparency (CTT) team sits within R&D Oncology Regulatory Science Strategy and Excellence (ORSSE) Clinical Trial Transparency Position Globally. CTT is responsible for posting clinical trial information to public websites and prepare clinical documents and data so they can be shared publicly meeting regulatory requirements and company commitments.

The CTT Redaction Analyst will be a specialist in clinical document redactions. They will redact clinical study documents in support of the EU Clinical Trial Regulation (for Clinical Trial Information System postings /CTIS/ and FDAAA801 with Final Rule /for Clinicaltrials.gov postings/ ). The individual is accountable to redact submission ready documents to ensure no personal data or commercially confidential information remains visible. They will support process growth, stability, and improvements in support of delivery of redacted clinical documents to be published on CTIS or on Clinicaltrials.gov.

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 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

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 requestors 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.

Typical Accountabilities and required competencies

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 deliver to the regulatory policies and support protection of personal information. Support development of any training materials when needed in collaboration with direct manager. Ensure adherence to all applicable AstraZeneca requirements, including but not limited to clinical operations, quality, best practices in managing confidential business information, and data privacy. Demonstrate 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 increasing delivery efficiencies as this capability grows. Support and engage study teams to ensure timely delivery of redacted documents in line with the process. Project opening for new requests Provide administrative support for tools used in the process Be a system expert in the use of technology/ tools Contribute to the new technologies/systems/tools development by providing user feedback or participating in testing Support the delivery of all Clinical Trial Transparency activities at AstraZeneca as assigned.

Education, Qualifications, Skills and Experience

Essential

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

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

3. Concentration on a task with repeatable delivery needs.

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

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

6. BSc computer science, business or life sciences.

Desirable

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

2. Good understanding of Global Medicines Development.

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

4. Adobe Acrobat software experience and understanding

Date Posted

05-sie-2026

Closing Date

17-sie-2026

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 authorization and employment eligibility verification requirements.