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    Medical Data Reviewer

    Caidya
    0-2 years
    Not Disclosed
    Remote
    12 Nov. 4, 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, CPC Certified, 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: Medical Data Reviewer
    Location: India (Remote)

    Job Overview:
    The Medical Data Reviewer is responsible for conducting medical data reviews focused on safety and efficacy parameters as outlined in the Medical Data Review Plan (MDRP) for each project. This role may also involve limited data review tasks and associated responsibilities such as query formulation, documentation of reviews, and preparation of summary reports.

    Key Responsibilities:

    • Perform medical data review tasks to ensure compliance with applicable SOPs, Sponsor/Client directives, and GCP guidelines.
    • Review and contribute to the design of eCRF fields relevant to medical data review.
    • Develop, input, and review project-specific Medical Data Review Plans (MDRPs) or equivalent documents.
    • Implement medical data review tools, including listings, patient profiles, and visual analytics.
    • Review various types of medical data, including vital signs, laboratory tests, ECG results, imaging results, adverse events, and efficacy assessments.
    • Generate and review medical queries and assist in their closure.
    • Prepare project-specific reports and provide training for new team members on medical data review processes and tools.
    • Attend project-specific meetings and data review meetings as required.
    • Review medical coding for accuracy and re-code as necessary.
    • Document significant communications with sites, clients, and internal teams.
    • Perform additional tasks and responsibilities as assigned.

    Additional Responsibilities (as needed):

    • Collaborate with project teams on integrated data review, providing medical expertise.
    • Work closely with Safety/Pharmacovigilance, Project Management, Clinical Operations, Data Management, Biostatistics, and QA to ensure effective execution of medical data review functions.
    • Participate in meetings with clients as requested.

    Supervisory Responsibilities:

    • No supervisory responsibilities.

    Job Requirements:

    Education:

    • Physician Assistant, MBBS/MD, Nurse Practitioner (or equivalent).

    Experience:

    • At least 1 year of clinical experience post-degree and 2 years in the Pharmaceutical, Biotech, Medical Device, or CRO industry with clinical data.
    • Highly desirable: Experience in a medical or drug development environment performing medical data reviews using visual analytics programs (e.g., Spotfire, Tableau, Power BI) and experience in oncology studies.

    Skills/Competencies:

    • Clinical thinking with the ability to use data review tools and formulate effective queries.
    • Understanding of scientific principles behind therapies and disease-induced pathology.
    • Strong knowledge of the drug/device/vaccine development process and ICH GCP guidelines.
    • Excellent time management and prioritization skills.
    • Effective communication skills in English, both oral and written.
    • Attention to detail and creative problem-solving skills.
    • Team player with integrity and professionalism.

    Capabilities:

    • Proficient in computer use and EDC programs.
    • Valid driver’s license and ability to travel (up to 10% if needed).
    • Must possess a credit card for travel expenses.
    • Ability to work remotely.

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