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    Medical Data Review Mgr

    Fortrea
    6-7 years
    Not Disclosed
    Bangalore
    10 Oct. 29, 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 Opportunity: Medical Data Review Manager

    Company: Fortrea
    Location: Bangalore
    Job Type: [Insert Job Type]

    Company Overview

    Fortrea is a leading global contract research organization (CRO) dedicated to scientific rigor and clinical development excellence. We provide pharmaceutical, biotechnology, and medical device customers with a broad range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

    Job Description

    The Medical Data Review Manager is a key member of the Global Medical Review Team, responsible for executing essential Medical Data Review activities. This role involves collaborating with the study team to oversee clinical deliverables and monitor remote aspects of clinical trials, ensuring compliance and effective risk management.

    Key Responsibilities:

    • Collaborate in the development of Central Monitoring proposal text and cost reviews, contributing to proposal strategy when Central Medical Review is involved.
    • Support sponsor presentations and bid defenses.
    • Ensure timely and accurate tracking and status reporting.
    • Evaluate safety signals based on individual cases and cumulative data assessments.
    • Contribute to the Risk Assessment and Categorization Tool related to medical review.
    • Support the Data Expert with critical data and EDC design implementation.
    • Draft and maintain the Central Medical Review Configuration Plan throughout the study.
    • Manage the configuration of the Xcellerate® Medical Review tool, including user acceptance testing.
    • Perform ongoing Central Medical Review, discuss findings with the Project Physician, and ensure issues are resolved.
    • Communicate data-driven decisions effectively to key stakeholders.
    • Ensure inspection readiness for medical assessment activities and support regulatory inspections as needed.
    • Collaborate with other Central Monitoring activities for consistency and effectiveness.
    • Provide training on project processes to new team members.

    Experience and Qualifications

    • Experience: Medical doctors with 6-7 years of experience in Medical Data Review.
    • Location: Must be based in Bangalore and able to work hours from 2 PM to 11 PM IST.
    • Education: Medical degree (MBBS/MD).

    Why Join Fortrea?

    At Fortrea, we are passionate about overcoming barriers in clinical trials. Join our exceptional team and thrive in a collaborative environment that supports personal growth while making a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

    Equal Opportunity Employer

    Fortrea is proud to be an Equal Opportunity Employer. We value diversity and inclusion and do not tolerate harassment or discrimination of any kind. Employment decisions are made based on business needs and individual qualifications without regard to race, religion, color, national origin, gender, family status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

    For more information about how we collect and store your personal data, please see our Privacy Statement.

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