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    Clinical Data Specialist

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    Kumaran
    To know about clinical data

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    Clinical Data Specialist

    Uploaded by

    Kumaran
    5 views3 pages
    To know about clinical data

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    © © All Rights Reserved

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    To know about clinical data

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    5 views3 pages

    Clinical Data Specialist

    Uploaded by

    Kumaran
    To know about clinical data

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
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    Clinical Data Specialist

    Job ID
    393921BR
    May 07, 2024
    India

    Summary

    -Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within
    schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical
    trial(s). Core member of the Clinical Trial Team, Contributes to operational excellence through process
    improvement and knowledge sharing

    About the Role

    Major accountabilities:

    Contributes to all operational/clinical trial deliverables that are in scope of the specific JD, according to
    timelines, budget, operational procedures, quality /compliance and performance standards.
    Conduct/Contribute to study start-up activities such as overseeing protocol development, CRF
    development, Informed Consent Form development.
    May/may not be involved in identifying new sites for clinical trials; analyze capability and make
    recommendation for trial inclusion.
    Ensuring proper handling of all study conduct and close out activities including but not limited to site close
    out, final drug accountability and audit readiness of Trial Master File documentation (if in scope of the
    specific JD).
    Responsible for education, implementation and compliance to standards (SOPs) and best practices for
    clinical operations/clinical data review activities within assigned clinical trial(s) and within clinical
    program(s), including sharing lessons learned.
    Reporting of technical complaints / adverse events / special case scenarios related to Novartis products
    within 24 hours of receipt -Distribution of marketing samples (where applicable)

    Key performance indicators:

    Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in
    compliance with quality standards.
    Proactive operational planning with effective contingency and risk mitigation plans.
    Adherence to Novartis policy and guidelines and external regulations

    Minimum Requirements:
    Work Experience:

    Operations Management and Execution.


    Project Management.
    Financial Management.
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    Collaborating across boundaries.

    Skills:

    Trial Planning and Feasibility.


    Over The Counter Product Development.
    Post Authorization Data Safety.
    Regulatory Strategy.
    Clinical Trial Set-up, Management & Conduct.

    Languages :

    English.

    Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a
    community of smart, passionate people like you. Collaborating, supporting and inspiring each other.
    Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
    https://www.novartis.com/about/strategy/people-and-culture

    Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay
    connected and learn about suitable career opportunities as soon as they come up:
    https://talentnetwork.novartis.com/network

    Division
    Biomedical Research
    Business Unit
    Pharma Research
    Location
    India
    Site
    Hyderabad (Office)
    Company / Legal Entity
    IN10 (FCRS = IN010) Novartis Healthcare Private Limited
    Functional Area
    Research & Development
    Job Type
    Full time
    Employment Type
    Regular
    Shift Work
    No
    Apply to Job

    Novartis is committed to building an outstanding, inclusive work environment and diverse teams'
    representative of the patients and communities we serve.

    2/3
    Job ID
    393921BR

    Clinical Data Specialist

    Apply to Job

    Source URL: https://www.novartis.com/careers/career-search/job/details/393921br-clinical-data-specialist-0

    List of links present in page

    https://www.novartis.com/about/strategy/people-and-culture
    https://talentnetwork.novartis.com/network
    https://novartis.wd3.myworkdayjobs.com/en-US/Novartis_Careers/job/Hyderabad-Office/Clinical-Data-
    Specialist_393921BR

    3/3

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