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    Medical Data Review Manager

    Fortrea
    5-7 years
    Preferred by Comapny
    Bangalore
    11 Nov. 25, 2024
    Job Description
    Job Type: Full Time Education: MBBS/MD 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

    About Fortrea

    Fortrea is a leading global contract research organization (CRO) with a legacy of scientific excellence and decades of clinical development expertise. Operating in over 90 countries, Fortrea partners with pharmaceutical, biotechnology, and medical device companies to deliver innovative clinical development, patient access, and technology solutions across 20+ therapeutic areas.

    Role Overview

    The Medical Data Review Manager will be a vital part of the Global Medical Review Team, ensuring the effective execution of key medical data review activities. The role involves oversight of clinical deliverables, collaboration with study teams, and implementing compliant risk plans using advanced tools like Xcellerate® Medical Review.

    Key Responsibilities

    Medical Data Review and Monitoring

    • Oversee and execute Central Medical Review tasks, including Xcellerate® Medical Review configuration, user acceptance testing, and ongoing reviews.
    • Draft and maintain Central Medical Review Configuration Plans and Central Monitoring Plans.
    • Analyze clinical data to identify and evaluate patient safety concerns and safety signals using individual case assessments and signal detection systems.

    Collaboration and Risk Management

    • Contribute to proposal strategy, development, and costing for Central Monitoring initiatives.
    • Collaborate with Central Monitoring Managers and project physicians to address identified risks and refine study-specific configurations.
    • Provide data-driven insights and communicate them to stakeholders proactively.

    Process Improvement and Training

    • Evaluate and propose process improvements and system/tool enhancements.
    • Train new team members on medical review processes and tools.

    Regulatory Readiness

    • Ensure inspection readiness for medical data review activities.
    • Support regulatory authority inspections and maintain compliance with risk plans.

    Qualifications and Requirements

    Education

    • Medical Doctor (MBBS/MD).

    Experience

    • 6-7 years of experience in medical data review.

    Skills

    • Proficiency in tools like Xcellerate® Medical Review and understanding of clinical trial data.
    • Strong analytical, problem-solving, and communication skills.
    • Ability to collaborate effectively with cross-functional teams.

    Why Join Fortrea?

    • Global Impact: Play a critical role in accelerating the development of life-changing therapies.
    • Collaborative Environment: Work alongside motivated, innovative problem-solvers.
    • Professional Growth: Nurture your career in a company committed to excellence.

    How to Apply

    Visit www.fortrea.com and reference job requisition ID 2440719. Ensure to apply before December 2, 2024.

    Fortrea is an Equal Opportunity Employer, fostering diversity and inclusion while prohibiting discrimination and harassment in any form. We encourage applications from individuals of all backgrounds.

    For more details on how your data is managed, refer to our Privacy Statement.

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