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    Senior Scientist I, Clinical Trial Safety

    Astrazeneca
    4+ years
    Not Disclosed
    Boston
    10 July 24, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior Scientist I, Clinical Trial Safety

    Career Level - D

    Introduction to the Role

    Are you driven by a passion for science and its potential to transform patients' lives? Do you have a strong background in Life Sciences and experience in clinical studies? If so, AstraZeneca has an exciting opportunity for you as a Senior Scientist I in Clinical Trial Safety. In this role, you will be part of our Biopharmaceuticals R&D team, collaborating with core and extended study teams throughout all stages of clinical trials. Your work will ensure that patient data is complete, medically accurate, and ready for interpretation by study physicians and clinical scientists, supporting our global commitment to improving patient access to healthcare.

    Key Responsibilities

    In this position, you will:

    • Ensure consistent processes and efficient review of critical clinical/safety data.
    • Continuously review patient-level clinical/safety data, prepare aggregated data visualizations, and facilitate safety data review meetings at the study level.
    • Contribute to study start-up activities and be an active member of the Extended Study Team.
    • Play a crucial role in developing automated patient narratives and managing handwritten patient narrative processes.
    • Lead the quality assurance of your deliverables and undertake tasks assigned by the Directors and Associate Directors of Clinical Trial Safety.

    Essential Skills/Experience

    • Educational Background: BSc/MSc/PhD in Life Sciences or equivalent work experience in related fields (e.g., medicine, pharmacy, veterinary, biotechnology, nursing, dentistry).
    • Clinical Study Experience: Minimum of two years working on clinical studies and/or study safety methodology.
    • Process Knowledge: Understanding of the clinical study and drug development process.
    • Regulatory Knowledge: Familiarity with ICH/GCP Guidelines and SAE reporting requirements.
    • Skills: Strong quality focus, analytical skills, and the ability to succinctly summarize complex information.
    • Time Management: Proven ability to prioritize and manage multiple tasks with conflicting deadlines.
    • Communication: Excellent interpersonal and communication skills, both verbal and written.
    • Teamwork: Ability to work collaboratively in teams as well as independently.
    • Cross-Functional Work: Willingness to work with internal and external partners on global studies across various phases of drug development or therapy areas.
    • Adaptability: Ability to manage change and uncertainty.
    • Technical Proficiency: Strong computer skills.
    • Language: Proficiency in spoken and written English.

    Desirable Skills

    • Experience with data review tools such as JReview, JMP Clinical, Spotfire, or EDC.
    • Ability to review, analyze, and interpret aggregated data.
    • Advanced computer skills to enhance daily task efficiency.
    • Experience in medical writing and/or producing patient narratives.

    At AstraZeneca, we believe that bringing together diverse teams fosters bold thinking, leading to life-changing medicines. Our work environment encourages collaboration, connection, and innovation, with a balance of in-office work and individual flexibility.

    Why Join Us?

    At AstraZeneca, we are dedicated to following the science wherever it leads. We are committed to treating, preventing, modifying, and even curing some of the world's most complex diseases. Our shared belief in the power of science drives us to redefine what's possible. By listening and learning from those affected by the diseases we target, we better understand their needs and can design treatments that make a real difference in their lives. We leverage digital technologies, data science, and AI to propel us towards the next wave of breakthroughs.

    Are you ready to make a meaningful impact? Apply now and join us in pushing the boundaries of science to deliver life-changing medicines!

    Commitment to Diversity and Inclusion

    AstraZeneca is committed to diversity and equality of opportunity. We strive to build an inclusive and diverse team, representing a wide range of backgrounds and perspectives, and harnessing industry-leading skills. We believe that inclusivity enhances our work and welcome applications from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment, recruitment, work authorization, and employment eligibility verification requirements.

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