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    Clinical Data Specialist

    Fortrea
    2+ years
    Not Disclosed
    Bangalore
    10 Nov. 6, 2024
    Job Description
    Job Type: Full Time Remote 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 Associate at Fortrea

    As a leading global contract research organization (CRO) with a commitment to scientific rigor and decades of clinical development experience, Fortrea delivers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, we are transforming drug and device development to improve outcomes for partners and patients worldwide.

    We are looking for a Data Management Associate to join our team. In this role, you will be responsible for supporting the data management aspects of clinical trials and ensuring all data-related tasks are completed in compliance with project protocols, SOPs, and GCP standards. You will assist in clinical data reviews, resolve discrepancies, and support the timely completion of all database-related activities.

    Key Responsibilities:

    • Project Execution: Ensure allocated data management projects are carried out in strict compliance with relevant protocols, SOPs, and GCP standards.
    • Study Timelines: Demonstrate the ability to read and follow study timelines, ensuring on-time deliverables. Assist with inputs into study design and suggest adjustments to timelines when necessary.
    • Data Review: Assist in reviewing clinical trial data according to the Data Management Plans (DMP) and Data Review Guidelines. Raise queries to address erroneous, missing, or incomplete data.
    • Program Execution: Run and execute additional programs, such as special listings and reconciliation discrepancy listings, to support clinical data review activities.
    • Query Management: Generate, resolve, and track queries to address problematic data identified during aggregate data review.
    • Collaboration: Interact with project team members to support the set-up, maintenance, and closure of the data management aspects of the project and attend meetings as required.
    • Data Listings: Generate and quality-check data listings for internal review and reporting.
    • Testing: Assist with or create dummy data for testing database screens, edit checks, SAS reports, and data listings.
    • Documentation: Post Data Management documentation and assist with eTMF maintenance and related administrative tasks as requested.
    • Reporting: Run study status reports and prepare reports for Sponsor meetings or other sponsor requests.
    • Database Lock: Assist with database lock and unlock activities.
    • Training: Support the training of new staff on project-specific Data Management processes.
    • Other Duties: Perform other duties as assigned by management.

    Minimum Required Qualifications:

    • Experience: 3-5 years of relevant data management experience, with knowledge of one or more therapeutic areas.
    • Time Management: Strong time management skills and the ability to meet project productivity metrics and timelines.
    • Medical Terminology: Knowledge of medical terminology is preferred.
    • Clinical Data Management: A good understanding of effective clinical data management practices.

    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 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. For more information about Fortrea, visit www.fortrea.com.

    Fortrea is proud to be an Equal Opportunity Employer. As an EOE/AA employer, we strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual, without discrimination on the basis of race, religion, gender, disability, veteran status, sexual orientation, gender identity, or any other legally protected characteristic.

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