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    Associate Director, Clinical Database Developer I

    Astrazeneca
    7+ years
    Not Disclosed
    Remote, USA
    10 Oct. 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, 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 ID: R-209069
    Date Posted: September 18, 2024
    Career Level: E

    Role Overview

    Join our Oncology R&D department as an Associate Director, Clinical Database Developer I. In this key role, you will oversee Clinical Database Development (CDD) deliverables at the clinical project or therapeutic area level, ensuring the harmonization and standardization of clinical databases across studies. As a recognized expert in CDD processes, standards, and technology, you will provide technical expertise to Clinical Project Teams (CPT) and work on cutting-edge drug modalities.

    Key Responsibilities

    • Oversight and Standardization: Ensure the standardization and harmonization of clinical database deliverables across studies within the clinical project or therapeutic area.
    • Technical Expertise: Provide project-level technical support to Clinical Project Teams, data management, medical, analysis, reporting, and study management teams during all study start-up activities.
    • Innovation and Automation: Lead initiatives to automate and simplify processes, positioning the team as an industry leader.

    Essential Skills and Experience

    • Education: Bachelor's degree in computing or a scientific discipline.
    • Database Development: Experience in database development within the pharmaceutical industry, specifically with clinical trial data.
    • Clinical Knowledge: Strong understanding of clinical trial processes and the pharmaceutical drug development lifecycle.
    • Communication Skills: Excellent written and verbal communication skills, with the ability to lead tasks from concept to delivery.
    • Organizational Skills: Exceptional organizational and analytical skills, with high attention to detail.
    • Project Management: Strong planning, resource, and project management skills.
    • System Design Knowledge: Understanding of clinical data system design, development, validation, and system interoperability.
    • Team Collaboration: Ability to work independently and as part of a global team.
    • EDC Tools: Experience with EDC tools such as Medidata Rave, Inform, Veeva, etc.
    • Data Standards Knowledge: Familiarity with data standards (CDISC) and practices related to CRF design, clinical data tabulation, and reporting.
    • Management Experience: 3-5 years of line management experience.
    • External Partner Collaboration: Proven ability to work effectively with external partners.

    Preferred Qualifications

    • Programming Experience: Knowledge of object-oriented programming using .NET technologies, C#, Visual Basic, MS SQL, SAS, Python, APEX, PL SQL, XML, or Java is a plus.
    • Reporting Tools: Experience with reporting environments such as Crystal Reports, Business Objects, TIBCO SpotFire, Power BI, or Tableau is advantageous.
    • Medidata Expertise: Familiarity with Medidata's Rave Study Build, Custom Functions, Rave Safety Gateway, and TSDV.

    Work Environment

    At AstraZeneca, we believe in the power of collaboration. We work, on average, a minimum of three days per week from the office, balancing in-person connection with individual flexibility.

    Commitment to Diversity

    AstraZeneca is committed to building an inclusive and diverse team that represents all backgrounds and perspectives. We welcome applications from all qualified candidates and comply with all applicable laws regarding non-discrimination in employment.

    Ready to make a difference? Apply now and join us in our mission to eliminate cancer as a cause of death!

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