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    Clinical Data Specialist

    Fortrea
    2+ 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: Data Management Specialist

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

    Company Overview

    As a leading global contract research organization (CRO), Fortrea is dedicated to scientific rigor and possesses decades of clinical development experience. We offer 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.

    Role Overview

    Fortrea is seeking a motivated Data Management Specialist to ensure that all allocated projects comply with relevant protocols, global SOPs, and GCP standards. This role involves data review, query resolution, and supporting the overall data management aspects of clinical trials.

    Key Responsibilities

    • Ensure compliance with study protocols, global SOPs, and GCP standards for all allocated projects.
    • Follow study timelines to ensure on-time deliverables and provide input on study design when warranted.
    • Review clinical trial data according to Data Management Plans and raise queries to resolve issues related to erroneous or incomplete data.
    • Execute programs for additional data review support, including special listings and reconciliation discrepancy listings.
    • Generate, resolve, and track queries during aggregate data review activities.
    • Collaborate with project team members on the setup, maintenance, and closure of Data Management aspects of projects.
    • Generate and perform quality control on data listings for internal review.
    • Create dummy data to test edit checks, database functionality, and SAS reports.
    • Review Edit Check Specifications and Database specifications for accuracy.
    • Maintain eTMF and perform data management-related administrative tasks as required.
    • Run study status reports in preparation for Sponsor meetings and specific requests.
    • Assist with Database Lock and Unlock activities.
    • Support the training of new staff on project-specific Data Management processes.
    • Perform any other duties as assigned.

    Qualifications

    • 3 to 5 years of relevant experience in data management, with knowledge of one or more therapeutic areas.
    • Strong time management skills and ability to adhere to project productivity metrics and timelines.
    • Knowledge of medical terminology is preferred.
    • Understanding of effective clinical data management practices.

    Why Join Fortrea?

    At Fortrea, we are committed to revolutionizing the clinical development process, ensuring the swift delivery of life-changing therapies to patients in need. Join our exceptional team and thrive in a collaborative environment that nurtures personal growth and enables you to make a meaningful global impact.

    Equal Opportunity Employer

    Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are 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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