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    Senior Standards Developer Ii – Rave Subject Matter Expert

    Astrazeneca
    5+ years
    Not Disclosed
    Remote, USA
    10 Dec. 17, 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, CPC Certified, 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 Standards Developer II – RAVE Subject Matter Expert
    Location: [Location]
    Job ID: R-215188
    Date Posted: 12/16/2024

    Introduction to the Role:
    Are you ready to make a significant impact in the field of clinical data standards? As a Senior Standards Developer II – RAVE Subject Matter Expert, you will be responsible for developing, managing, and maintaining complex data collection and cleaning components within the RAVE Global Library of Clinical Data Standards. Your technical proficiency and deep industry knowledge will enable you to provide expert solutions for data collection and cleaning, ensuring compliance with both industry and company standards. This role will allow you to lead RAVE component deliverables and serve as the primary subject matter expert for cross-functional projects.

    What You'll Do:

    • Develop and Manage Standards: Develop, manage, and maintain high-complexity data collection and cleaning components in the RAVE Global Library.
    • Ensure Quality: Perform independent quality control and lead team activities to ensure high-quality deliverables.
    • Collaboration: Contribute to Clinical Standards governance groups and provide expert support on drug projects in alignment with AZ Clinical Standards.
    • Mentoring: Contribute to function recruitment, training, and mentoring, ensuring the development of best practices.
    • External Partnerships: Manage activities and ensure quality in collaboration with external partners.
    • Subject Matter Expertise: Serve as the technical subject matter expert on RAVE components, providing expert guidance to cross-functional teams.
    • Metrics Reporting: Assist with metric reporting on standards and requests, ensuring transparency and process efficiency.

    What You'll Need:

    • Educational Background: BSc in Information Sciences, Mathematical, Statistical, Computer Science, Life Science, or equivalent experience.
    • Experience in RAVE: 5+ years of experience in RAVE, including programming custom functions.
    • Certification: Medidata study build certificate (SDBE) required.
    • Programming Skills: Strong understanding of RAVE custom functions and advanced C# programming skills.
    • Industry Knowledge: Familiarity with CDISC-CDASH/SDTM and validation processes.
    • Technical Proficiency: Knowledge of MS Excel, and programming languages such as SAS, R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, and Pearl.
    • Attention to Detail: A systematic approach with deep attention to details in data management and system design.
    • Project Management: Strong project management skills to manage multiple activities and tasks concurrently.
    • Communication Skills: Excellent communication skills in both written and spoken English.

    Preferred Qualifications:

    • Additional Knowledge: Experience with Rave Safety Gateway, and the ability to apply technical knowledge to problem-solving.
    • Industry Standards: Understanding of clinical development processes and ability to optimize form design using field attributes, log forms, dynamics, and edit check actions.

    Why AstraZeneca:
    At AstraZeneca, we are committed to pushing the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. Our innovative approach includes novel biomarkers, AI, groundbreaking trial designs, and life-changing medicines that improve patient outcomes. We foster a collaborative environment that empowers individuals to take smart risks, challenge norms, and continuously learn. Join us in our mission to eliminate cancer as a cause of death.

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    South Africa | Midrand |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |