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    Sr Clinical Data Specialist

    Fortrea
    5+ 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: Lead Data Reviewer

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

    Company Overview

    Fortrea is a leading global contract research organization (CRO) committed to scientific rigor and decades of clinical development experience. 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 Summary

    As a Lead Data Reviewer, you will serve as a key member of the project team with primary responsibility for clinical data review, query generation/resolution, and reconciliation. You will support the delivery of clinical data according to client quality and integrity specifications, project timelines, and productivity targets. This role may also involve assisting in the development of the project Data Management Plan and serving as the operational data management leader on smaller projects.

    Key Responsibilities

    • Review clinical trial data in accordance with global Data Management Plans and applicable standardized processes (SOPs, Work Instructions) to identify erroneous, missing, or implausible data.
    • Run ancillary programs (e.g., diagnostics, reconciliation discrepancy listings) to support clinical data review.
    • Generate, resolve, and track queries to address problematic data identified during review activities.
    • Perform aggregate reviews of clinical data by patient, site, or project to identify trends and inconsistencies requiring further investigation.
    • Apply quality control procedures to ensure data quality standards are met.
    • Assist in the development of global Data Management Plans and Quality Management Plans for accurate, timely, and quality clinical data.
    • Contribute to the review of database design and annotate the CRF/eCRF according to specifications.
    • Create and assist in developing data review guidelines consistent with clinical data models and monitoring conventions.
    • Assist in testing data management system edit and validation checks, as well as special procedures for data review.
    • Support the Lead Data Manager or Lead Data Reviewer in building timelines to meet contracted milestones.
    • Ensure service and quality meet agreed specifications per the DMP and budget.
    • Inform the Lead Data Reviewer of budget overages and assist in the Change Order Log process.
    • Perform quality control on data management activities, including documentation and query generation.
    • Support and resolve issues during client or internal audits in a timely manner.
    • Mentor and coach project staff on project-specific data management processes.
    • Perform any other related duties as assigned.

    Why Join Fortrea?

    Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Join our exceptional team and thrive in a collaborative environment that fosters personal growth and enables you to make 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 are committed to diversity and inclusion in the workforce 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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