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    Job · 21988137

    Bristol-Myers Squibb logo

    Clinical Trial Results Manager

    Bristol-Myers Squibb · Hyderabad · onsite · Posted 5d ago

    Undisclosed3–8 yrsfulltimeSourced fromNaukri

    About a minute. You'll make an account on the way through.

    About this role

    Key Responsibilities
    • Identifies result summary data to be disclosed based on the protocol and study report.
    • Creates the results reporting form for a clinical trial based on information found in the clinical study report.
    • Manages the review and approval process for the results form, uploads completed and approved forms to ClinicalTrials.gov and EudraCT/CTIS.
    • Partners with DQS and external partners to ensure AE xml files for results disclosure are created and uploaded to the database.
    • Files reporting extensions (certificates of delay) when appropriate.
    • Liaises with Statisticians, Clinical Trial Physicians, Patent Attorneys, Global Trial Manager, and Medical Writers on all trials - operates as part of team to ensure the data best supports results and is consistent with other public forms of trial results (i. e. publication in a clinical journal)
    • Provides operational support for other pillars of Clinical Trial Transparency, as needed
    • Assesses revised protocols for impact on registration, and works with the study team on registration updates.
    • Publishes CSR synopsis on BMS.com
    • Contributes to improvements of clinical trial data disclosure processes and related documentation.
    • Support Plain Language Summary (PLS) activities, as needed.



    Requirements
    • BS, MS, or PhD in scientific or medical field
    • Minimum of 3 years overall work experience
    • Demonstrated Excel and analytical skills
    • Bachelor s degree in a life science field with 2+ years of technical or preferably scientific writing experience



    Ideal Candidates Would Also Have
    • Work experience in quality, regulatory, compliance, clinical research or drug development, clinical research preferred
    • Familiarity with clinical trial protocols and reports desirable


    Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

    Sourced from naukri

    Skills

    drug developmentanalytical thinkingLIFESCIENCEclinical researchdata privacylosoperational supportbsCSRclinical study reportPLSXMLResearchcompliance

    About Bristol-Myers Squibb

    Bristol-Myers Squibb logo

    Bristol-Myers Squibb

    Pharma

    375

    employees

    1887

    139 years old

    New York

    United States

    ₹19.1L PA avg

    Avg at Bristol-Myers Squibb

    About

    We are a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. At Bristol Myers Squibb, we work every day to transform patients’ lives through science. We combine the agility of biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation. We have the brightest people in the industry and believe that their diverse experiences and perspectives help to bring out our best ideas, drive innovation and achieve transformative business results. Each day, our employees around the world work together for patients – patients are at the center of everything we do. They inspire us. They are the reason we come to work each day. We are proud of the advancements we have made in oncology, hematology, immunology, and cardiovascular disease, and we are dedicated to helping patients prevail over serious diseases through our diverse and promising pipeline and new scientific platforms. We are pursuing therapies at the forefront of scientific discovery with the goal of bringing an exciting new generation of life-changing treatments to patients. We aspire to be at the center of a vibrant healthcare innovation ecosystem, where academic research centers, biotech, and biopharma companies all contribute to continued scientific advancement.

    Industries

    PharmaBiotech & Life sciences

    Employee ratings

    10 reviews

    3.7/ 5

    Culture

    2.6

    Career growth

    2.2

    Work-life

    3.1

    Employees rate it well for

    Work-Life Balance38Compensation & Benefits37

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