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    Medical Data Reviewer

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    5-8 years
    Not Disclosed
    Remote
    15 June 6, 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, 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: Clinical Data Reviewer

    Company: ICON plc

    Industry: Healthcare Intelligence and Clinical Research

    About ICON plc:

    ICON plc is a world-leading healthcare intelligence and clinical research organization committed to fostering an inclusive environment that drives innovation and excellence. Join us on our mission to shape the future of clinical development.

    Role and Responsibilities:

    Primary Duties:

    • Serve as a Clinical Data Reviewer to identify errors and perform data reviews requiring clarification with the study site.
    • Conduct ongoing reviews of clinical/medical aspects of patient data and documents, escalating issues to the Client Clinical Scientist or medical monitor as necessary.
      • Review patient eligibility, diagnosis, medical history, prior treatments, study drug administration, AE/SAE/AESI, concomitant medications, safety labs, efficacy assessments, EOT, EOS, survival, coding, etc.
      • Issue and manage clinical data queries, ensuring timely follow-up and resolution.
    • Communicate data training needs for CRAs and sites.
    • Conduct in-stream data trend analysis to support data quality and integrity, including protocol compliance and targeted patient data reviews.
    • Provide clinical data project management and expertise in data clinical/medical review and cleaning.
    • Ensure data quality focus to maintain audit readiness with Clinical Compliance and Systems Validation Compliance.
    • Assist in developing data capture requirements in line with protocol and reporting requirements.
    • Monitor site data entry performance, identify root causes of data issues, and implement remedial actions.
    • Continuously seek opportunities to improve task efficiency and data deliverable quality.
    • Participate in clinical data review meetings and contribute to data dissemination meetings, such as investigator meetings, advisory boards, and safety cohort review meetings.
    • Collaborate closely with Client Clinical Scientists, Medical Directors, Data Management, and Clinical Operations for clinical data reviews and activities before data cuts for snapshots, interim analysis, DSUR, IBs, regulatory requests, study site close-outs, and final DBL.

    Additional Duties:

    • Assist in preparing or reviewing materials for data dissemination meetings.
    • Review and QC clinical data sections for abstracts, manuscripts, and presentations.
    • Contribute to tracking and QC review of patient narratives for Clinical Study Reports (CSR).

    Required Experience and Skill Set:

    Education:

    • Educational background in a scientific field such as MD, PharmD, PhD, Nursing degree, or MSc.

    Experience:

    • ≥ 5 years of pharmaceutical clinical/medical data review experience, including clinical crosscheck experience (8+ years preferred).
    • Experience with solid tumor oncology.
    • Experience in coding review and query writing training.
    • Strong clinical database navigation skills.

    Skills:

    • Excellent verbal and written communication skills in English.
    • Strong organizational, tracking, and operational skills.
    • Proven ability to meet timelines and work both independently and in a team setting.
    • Detail-oriented with strong analytical and critical thinking skills.
    • Proficiency in MS Excel and project management.
    • Knowledge of Good Clinical Practice and comprehensive understanding of clinical trial design and the drug development process.

    What ICON can offer you:

    Benefits:

    • Various annual leave entitlements.
    • A range of health insurance offerings to suit you and your family’s needs.
    • Competitive retirement planning offerings.
    • Global Employee Assistance Programme (TELUS Health) offering 24-hour access to specialized professionals.
    • Life assurance.
    • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, and more.

    Diversity and Inclusion:

    At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. We strive to create a diverse workforce and inclusive environment for all candidates, free of discrimination and harassment. We encourage all qualified applicants to apply, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If you need reasonable accommodation for any part of the application process or to perform the essential functions of the position, please let us know.

    Interested in the role, but unsure if you meet all the requirements? We encourage you to apply regardless—there’s every chance you’re exactly what we’re looking for at ICON.

    For more information, visit our careers website: ICON Careers

    To request reasonable accommodations: Reasonable Accommodations

     

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