Oferta pracy

Senior Analyst, Clinical Trial Safety

AstraZeneca Pharma

  • Postępu 14, Warszawa
    Warszawa, Masovian
  • offer expired a month ago
  • contract of employment
  • full-time
  • expert
  • remote recruitment

AstraZeneca Pharma

Postępu 14

Warszawa

Your responsibilities

Development Operations within Biopharmaceutical R&D is accountable for the delivery of clinical studies.

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 medical (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 clinical/project scientists to interpret safety data efficiently.

The Senior Analyst, Clinical Trial Safety in Trial Safety Review Centre (TRISARC) is responsible for tools set-up, scripting, and data analysis tasks for the Trial Safety Review Center. The CTSA works closely with the Trial Safety Review Center staff to ensure safety data deliverables are executed per pre-defined plans and up to quality and timelines. The CTSA is adept at utilizing the Center’s Data Review tools of choice and should possess programming experience.

Typical Accountabilities:

• Ensure the Data Review tool is fit for purpose through set-up, maintenance and close-out of study according to agreed Best Practice procedures  – to allow for handling of safety data and review for medical completeness and medical accuracy

• Generate high quality Clinical/Safety Data Review reports that are aligned for TRISARC members and the Global Therapeutic Areas

• Work with data outputs (i.e. generate reports, complex data) from multiple sources such as the clinical database, external labs, ECG providers, and other safety vendors as appropriate.

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

• Work closely with IT and R&D Information functions to align on tool maintenance and tool improvement; provide customer feedback from the end user (TRISARC Safety Specialists, Study Physicians, Clinical Scientists)

• Take on ad-hoc tasks as assigned by the TRISARC Leadership team members (e.g., capacity reports, business intelligence)

Our requirements

  • University degree in related discipline

  • Minimum one year of experience working on clinical studies in the Biotech/Pharma/CRO industry or equivalent

  • Proven organizational and analytical skills

  • Understanding of the clinical study and drug development process

  • Knowledge of ICH/GCP Guidelines

  • Knowledge of SAE reporting requirements

  • Proven ability to prioritize and manage multiple tasks with conflicting deadlines

  • Ability to work independently, as well as in a team environment

  • Independently designing and planning own work

  • Managing change and uncertainty for self

  • Computer proficiency including Microsoft Outlook, Excel and Microsoft Power Platform

  • Excellent knowledge of spoken and written English

  • Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information

  • Exhibit of AZ Values and Behaviours

  • Relevant industry or health care experience

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

  • Good understanding of clinical data flow

  • Strong attention-to-detail, analytical skills, and ability to concisely summarize large amounts of complex information

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

  • Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities Experience using data review tools such as JReview, JMP Clinical, or Spotfire

  • Benefits

  • sharing the costs of sports activities

  • private medical care

  • sharing the costs of foreign language classes

  • sharing the costs of professional training & courses

  • life insurance

  • remote work opportunities

  • flexible working time

  • fruits

  • integration events

  • corporate gym

  • retirement pension plan

  • corporate credit card

  • video games at work

  • coffee / tea

  • drinks

  • parking space for employees

  • leisure zone

  • meal passes

  • sharing the costs of tourist services

  • holiday funds

  • sharing the costs of holidays for kids

  • christmas gifts

  • employee referral program

  • opportunity to obtain permits and licenses

  • charity initiatives

  • extra leave

  • annual bonus

  • glasses reimbursement

  • business travel insurance

  • Work anniversary award

AstraZeneca Pharma

At AstraZeneca every 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.

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