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    Medical Data Reviewer - Remote

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    5+ years
    Not Disclosed
    10 May 15, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Role Overview:

    ICON plc, a leading healthcare intelligence and clinical research organization, is seeking a Clinical Data Reviewer to join their team. This role involves ensuring the accuracy and integrity of clinical trial data by reviewing and analyzing patient data and documents, identifying errors, and collaborating with the study site and internal teams to resolve issues.

    Key Responsibilities:

    1. Clinical Data Review:

      • Review clinical/medical aspects of patient data and documents, including eligibility, diagnosis, medical history, treatments, adverse events, concomitant medications, safety labs, and efficacy assessments.
      • Issue clinical data queries and ensure timely follow-up on responses from study sites.
      • Conduct ongoing data trend analysis to support data quality and integrity.
      • Provide expertise in data clinical/medical review and cleaning.

    2. Project Management:

      • Manage clinical data projects and ensure compliance with protocols and reporting requirements.
      • Monitor site data entry performance and identify root causes of data issues.

    3. Communication and Collaboration:

      • Communicate data training needs to relevant stakeholders.
      • Collaborate with Clinical Scientists, Medical Directors, Data Management, and Clinical Operations to execute clinical data reviews and activities.
      • Participate in various clinical data review meetings and prepare materials for data dissemination meetings.

    4. Quality Assurance and Improvement:

      • Ensure audit readiness and compliance with clinical and systems validation.
      • Continuously assess opportunities to improve efficiency and quality of data deliverables.

    5. Documentation and Reporting:

      • Contribute to the preparation and review of clinical data sections for abstracts, manuscripts, presentations, and clinical study reports.

    Required Experience and Skills:

    • Educational background in MD, PharmD, PhD, Nursing, or MSc.
    • Minimum 5 years of pharmaceutical clinical/medical data review experience, preferably 8+ years.
    • Experience in Solid Tumor Oncology.
    • Strong verbal and written communication skills in English.
    • Detail-oriented with strong organizational and tracking skills.
    • Experience in coding review and query writing.
    • Proficiency in clinical database navigation, MS Excel, and project management.
    • Ability to work independently and collaboratively in a team setting.
    • Knowledge of Good Clinical Practice and clinical trial design.

    Benefits:

    ICON offers a competitive salary and a range of benefits, including various annual leave entitlements, health insurance options, retirement planning, employee assistance programs, life assurance, and flexible optional benefits tailored to each country.

    Diversity and Inclusion:

    ICON values diversity, inclusion, and belonging, fostering an inclusive environment that encourages innovation and excellence. The company is committed to providing equal employment opportunities and a workplace free of discrimination and harassment.

    Application:

    Interested candidates are encouraged to apply, even if they do not meet all requirements, as ICON believes in considering all potential candidates for roles within the organization.

    Further Information:

    For more details about ICON's benefits and to apply for the role, visit their careers website: ICON Careers Website 

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