AstraZeneca Clinical Trial Safety Job For BSc, MSc & PhD Life Sciences

AstraZeneca Clinical Trial Safety Job For BSc, MSc & PhD

AstraZeneca Clinical Data Manager Job For Life Sciences, Apply Online. BSc, MSc & PhD life sciences job opening. Clinical Trial Safety vacancy. AstraZeneca job openings. Interested and eligible applicants can check out all of the details on the same below

Hey there, before you run off to apply for this Senior Scientist I, Clinical Trial Safety role at AstraZeneca, then make sure you check out the possible interview questions and the answers below.

Post Name – Senior Scientist I, Clinical Trial Safety

Location – India – Bangalore

Job ID – R-160707

JOB TITLE:  SENIOR SCIENTIST I, CLINICAL TRIAL SAFETY

CAREER LEVEL: D

Take the lead to make a bigger impact

Here we need leadership at every level – Physicians who not only have expertise, but also the ability to build a business case, engage multiple stakeholders, and communicate effectively with different audiences. With that kind of remit comes great responsibility and the opportunity to make a big impact.

Be the beating heart of AstraZeneca. A science-driven organisation where

‘following the science’ is backed by investment and bold decision-making.

There’s no better place to see what science can do.

About AstraZeneca

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development

About the team

We’re a team of leading specialists, driven to pursue scientific knowledge. And there’s no better place to learn – from the science, from each other and from our failures.

It’s a dual role as we work on both understanding our patients better and contributing to scientific research. We are always learning from people who live with the diseases our medicines treat. So we can make sure that great science born in the lab can make a real difference to their lives.

About the role

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 they 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, they 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. They supports study teams via writing patient narratives for qualifying events, if applicable.

Key Accountabilities:

• 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
• Advance 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

Essential

• 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
• Great teammate, 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

WHY JOIN US ?

This is a place of opportunity with the support you need to thrive and grow. You can move around, try different areas and develop new skills.

Most importantly, we get to work on lifechanging medicines for people who face serious conditions. Our innovative discoveries will ultimately have the potential to reach billions of patients’ in need across the globe.

That’s why we love it – this is the place to make a greater impact

SO, WHAT’S NEXT?

Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.

APPLY ONLINE

Hey there, before you run off to apply for this Senior Scientist I, Clinical Trial Safety role at AstraZeneca, then make sure you check out the possible interview questions and the answers below.

1. What are the primary roles of the Trial Safety Review Center (TRISARC)? Answer: The primary role of TRISARC is to review clinical data (mainly safety) to ensure patient data is complete and medically accurate. This helps study physicians and/or clinical (project) scientists interpret medical/safety data efficiently.
2. What is the role of the Senior Scientist I, Clinical Trial Safety at AstraZeneca? Answer: The Senior Scientist I works closely with the core and extended study teams at every stage of the clinical trial. They ensure well-defined standards are outlined, appropriate eCRF modules and Safety Monitoring agreements are in place, and review 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. They also prepare aggregated data visualization, facilitate meetings related to review of safety data on study level and contribute to study start-up activities according to the applicable process/procedures.
3. What are the key accountabilities of the Senior Scientist I, Clinical Trial Safety at AstraZeneca? Answer: The key accountabilities of the Senior Scientist I include ensuring consistent processes and efficient review of critical clinical/safety data, contributing to study start-up activities, serving as a member of the Extended Study Team and reporting on TRISARC deliverables, working with study physicians and/or clinical/project scientists to support standardized high-level data review and medical evaluation, advancing urgent and critical medical cases to the study physician/medical scientist as appropriate, and providing input into the process of setting automated patient narratives.
4. What are some essential qualifications and skills required for the role of Senior Scientist I, Clinical Trial Safety at AstraZeneca? Answer: The essential qualifications and skills required for the role of Senior Scientist I include an 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 the 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, great teammate, able to work individually, ability and willingness to work cross-functionally, computer proficiency, excellent knowledge of spoken and written English, and exhibit of AZ Values and Behaviours.
5. What are some desirable qualifications and skills required for the role of Senior Scientist I, Clinical Trial Safety at AstraZeneca? Answer: Some desirable qualifications and skills required for the role of Senior Scientist I include experience using data review tools such as JReview, JMP Clinical, or Spotfire, EDC, ability to review/analyze and interpret aggregated data, ability to develop advanced computer skills to increase efficiency in day-to-day tasks, and experience in medical writing and/or producing patient narratives.

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