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Bengaluru

    Medical Data Reviewer - Bengaluru, India - ICON Strategic Solutions

    ICON Strategic Solutions
    ICON Strategic Solutions Bengaluru, India

    2 days ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Serve as a Clinical Data reviewer and identify any errors in data by performing data review that require further clarification with the study site. Perform ongoing review of clinical/medical aspects of assigned patient data and documents (escalates to Client Clinical Scientist and/or medical monitor, as appropriate)

    Examples include but not limited to: Patient eligibility, diagnosis, medical history and prior treatments, study drug administration, AE/SAE/AESI, con meds, safety labs, efficacy assessments, EOT, EOS, survival, coding, etc. Issues clinical data queries and ensure timely follow up following site responses as to whether the queries are appropriately addressed, and updates in EDC done, if

    applicable, by either closing out the queries or re-querying, as applicable

    Communicates any data training needs for CRAs, sites, etc.

    Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol

    compliance and targeted review of patient data)

    Provide clinical data Project Management and viewed as an expert in data clinical/medical

    review and cleaning.

    Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance.

    May assist in review and contribute to data capture requirements guidance in line with protocol and reporting requirements.

    Monitor site data entry performance and provide leadership to identify root causes of data issues and implement remedial actions.

    Ensure timely follow-up and resolution of data related compliance issues.

    Continuously assess opportunities to improve efficiency of tasks and quality of data deliverables. May contribute to EDC completion training.

    May participate in clinical data review meetings such as:

    o Protocol Deviation review

    o Data Review and Quality Team (DRQT)

    o Statistical Review of Clinical Data (SRCD)

    o Safety Monitoring Team (SMT) review

    o Slide preparation of top-line results

    May be involved in preparing or review material for and presents in data dissemination meetings, such as:

    • Investigator meetings, advisory boards, safety cohort review meetings, IDMC, SC, senior management meetings, central imaging review, CST/SPT/DPR/PRC discussions for study/program decisions
    • May be involved in review and QC clinical data sections for abstracts / manuscripts/ oral and poster presentations
    • Will collaborate closely with Client Clinical Scientists, Medical Directors, Data Management and Clinical Operations to execute clinical data reviews and activities prior to data cuts for snapshots, interim analysis, DSUR, IBs, regulatory requests, study site close-outs and final DBL.
    • May be closely involved in data review and identification of readiness for clinical narratives for Clinical Study Report (CSR)
    • May be involved in QC review of patient narratives and contribute to tracking of such.

    Required Experience and Skill Set:

    • Educational scientific background such as MD, PharmD, PhD, Nursing degree, MSc
    • ≥ 5 years of pharmaceutical clinical/medical data review experience is required, including clinical crosscheck experience. 8+ years is preferrable.
    • Experience with Solid Tumor Oncology
    • Excellent verbal and writing communication in English, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
    • Detail oriented
    • Experience in coding review
    • Query writing training
    • Strong clinical database navigation skills
    • Strong MS excel, project management
    • Proven ability to work independently and in a team setting.
    • Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.

    What ICON can offer you:

    Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

    In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

    Our benefits examples include:

    • Various annual leave entitlements
    • A range of health insurance offerings to suit you and your family's needs
    • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
    • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
    • Life assurance
    • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

    Visit our careers website to read more about the benefits of working at ICON:

    At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

    Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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