Senior Scientist I, Clinical Trial Safety permanent/fix term/secondment until Feb 2027)

Warszawa, mazowieckie
Stała
Pełny etat

7 dni temu

ABOUT ASTRAZENECAEvery one of our employees makes a difference to patient lives every day. You may not feel you’re at the frontline of research but your role in changing patients’ lives is critical. Our mission is ambitious, and it takes the skills of a collaborative team to really deliver on what science can do and to always put patients first. Working at AstraZeneca we believe in the potential of our people and our commitment to develop our people beyond what was thought possible.The Trial Safety Review Center (TRISARC) is a department in the Research and Development function of AstraZeneca. The primary remit of the TRISARC is to review large amounts of clinical (mainly safety) data flowing through the clinical trial environment in order to ensure patient data is complete and medically accurate thus allowing study physicians and/or clinical(project) scientists to interpret medical/safety data efficiently.The Senior Scientist I, Clinical Trial Safety works closely with the core and extended study teams at every stage of the clinical trial. During study set up he/she ensures well-defined standards are outlined and appropriate eCRF modules and Safety Monitoring agreements are in place. During the recruitment and maintenance phases of the clinical trial, he/she uses the Center’s data review tool to review and query important clinical/safety data within the scope agreed with Medical team and documented accordingly. The Senior Scientist I also prepares and facilitates meeting related to review of Study Level safety data. He/she supports study teams via writing patient narratives for qualifying events, if applicable.Job Responsibilities

Ensure consistent processes and efficient review of critical clinical/safety data

Review of patient-level clinical/safety data on an ongoing basis to ensure medical accuracy and completeness, coding consistency and generate applicable queries as needed to obtain information for appropriate medical assessment and case closure

Prepare aggregated data visualization and facilitate meetings related to review of safety data on study level

Contribute to study start-up activities according to the applicable process/procedures (ex. input to the applicable documents, tools set up)

Serve as a member of the Extended Study Team and report on TRISARC deliverables

Work with the study physicians and/or clinical/project scientists to support standardized high-level data review and medical evaluation

Escalate urgent and critical medical cases to the study physician/medical scientist as appropriate

Provide input into the process of setting automated patient narratives, if applicable

Provide input to establishing the process for handwritten patient narratives, including guideline development and the quality control process if applicable

Lead quality of own deliverables

Take on tasks as assigned by the Directors, Associate Directors Clinical Trial Safety

Provide input into non-drug project work including training activities, continuous improvement and development of procedures as needed

Education, Qualifications, Skills and Experience

Educational degree (BSc/Msc/PhD) in Life Science or equivalent work experience in directly related fields(preferably medicine, pharmacy, veterinary, biotechnology, nurse, dentist)

Minimum two years of experience working on clinical studies and/or study safety methodology

Understanding of the clinical study and drug development process

Knowledge of ICH/GCP Guidelines

Knowledge of SAE reporting requirements

Quality focus, analytical skills, and ability to concisely summarize large amounts of complex information

Proven ability to prioritize and manage multiple tasks with conflicting deadlines

Excellent time management

Very good interpersonal and communication skills

Team player, able to work individually

Ability and willingness to work cross-functionally, e.g. with internal and external partners, on global studies, across different phases of drug development or different therapy areas

Managing change and uncertainty for self

Computer proficiency

Excellent knowledge of spoken and written English

Exhibit of AZ Values and Behaviours

Desirable

Experience using data review tools such as JReview, JMP Clinical, or Spotfire, EDC

Ability review/analyze and interpret aggregated data

Ability to develop advanced computer skills to increase efficiency in day to day tasks

Experience in medical writing and/or producing patient narratives

What we offer:Welcome to Warsaw Site, one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s important to us that you bring your full self to work every day.To help you maintain your best self, here’s a sneak peek into some of the things this site provides for you:The best team to support you,Multisport card,Pension plan,Life insurance,after-work events,private medical carelunch card,bright and spacious environment,sustainable office working environment.Please note that we are working in a hybrid model of 3 days per week from the office in WarsawPlease be informed that we have different contract availability. Fixed-term/secondment until 31.09.2026Date Posted 28-sie-2025Closing Date 10-wrz-2025AstraZeneca 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.

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