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    Medical Data Review Associate Manager

    Fortrea
    3-6 years years
    upto 15 LPA
    Bangalore
    10 July 9, 2024
    Job Description
    Job Type: Full Time Education: MBBS / MD (Pharmacology) Skills: Causality Assessment, Communication Skills, GCP guidelines, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Medical Data Review Associate Manager

    Location: Bangalore, India
    Time Type: Full-time
    Posted On: Posted Yesterday
    Job Requisition ID: 2426233

    Company: Fortrea

    About Fortrea

    Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. Fortrea provides pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff operating in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe. For more information, visit www.fortrea.com.

    Job Summary

    The Associate Medical Data Review Manager is a crucial member of the Global Medical Review Team. This role is responsible for executing key Central Medical Review activities within the Central Monitoring strategy. The position involves collaborating within a matrix environment, communicating proactively with internal and external stakeholders, and ensuring the effective execution of Central Monitoring/Central Medical Review Plans.

    Key Responsibilities

    • Central Medical Review: Prepare and conduct Central Medical Review tasks across sponsor projects, from Xcellerate® Medical Review tool launch to study report completion.
    • Collaboration: Communicate and collaborate with key stakeholders to ensure effective execution of Central Monitoring/Central Medical Review Plans.
    • Review and Reporting: Conduct reviews under the Central Medical Review Plan, communicate findings, and provide support to the study team and client.
    • Proposal Development: Collaborate in developing Central Monitoring proposal text, reviewing costs, and contributing to proposal strategy.
    • Support: Support sponsor presentations and bid defenses.
    • Tracking and Reporting: Ensure timely and accurate tracking and status reporting.
    • Safety Evaluation: Identify and evaluate safety signals, recommend patient safety concerns, and apply data for assessment.
    • Risk Assessment: Contribute to the Risk Assessment and Categorization Tool for medical review topics.
    • Data and Process Definition: Support the Data Expert with Critical Data and Process Definition and EDC design implementation.
    • Medical Review Requirements: Develop requirements, design visualizations, and draft the Central Medical Review Configuration Plan.
    • Tool Management: Configure the Xcellerate® Medical Review (XMR) tool, program study-specific visualizations, and perform user acceptance testing.
    • Ongoing Review: Perform ongoing reviews, discuss findings, and ensure issues are resolved and documented.
    • Inspection Readiness: Ensure inspection readiness and support regulatory authority inspections as needed.
    • Process Improvement: Evaluate and submit process improvement suggestions and ideas for system and tool improvements.
    • Training and Mentoring: Provide training and mentorship to new team members.

    Qualifications

    • Education: Medical Doctors (MBBS); Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
    • Experience: 3-6 years of experience in medical practice or equivalent clinical research roles.

    Additional Information

    Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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