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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 Title: Clinical Data Reviewer Support
    Company: Fortrea
    Location: Remote
    #LI-Remote

    About Fortrea:

    Fortrea is a leading global contract research organization (CRO) that combines scientific rigor with decades of clinical development expertise. We offer a full range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Operating in over 90 countries, Fortrea is reshaping drug and device development for pharmaceutical, biotechnology, and medical device companies, driving advancements that help patients worldwide.

    Job Summary:

    As a Clinical Data Reviewer Support at Fortrea, you will be a key member of the project team, primarily responsible for supporting the Data Management team with the review of clinical trial data. You will assist in generating, resolving, and tracking data queries, ensuring data quality, and contributing to the development of Data Management Plans (DMPs), data review guidelines, edit checks, and eCRF specifications. Your role will help ensure the delivery of high-quality clinical data in accordance with client specifications and project timelines.

    Key Responsibilities:

    • Clinical Data Review & Query Management:
      Assist in the review of clinical trial data to identify erroneous, missing, or incomplete data and raise appropriate queries to resolve these issues.
    • Data Management & Quality Control:
      Support the setup, maintenance, and closure of data management activities. Ensure data is in compliance with global Data Management Plans (DMPs), Data Review Guidelines, and other relevant protocols.
    • Data Review & Documentation:
      Run and execute additional programs, including special listings and reconciliation discrepancy listings, to aid in the review of clinical data. Generate and QC data listings for internal review.
    • System Support:
      Assist in testing and creating dummy data to validate edit checks, SAS reports, and database design, ensuring all systems and tools function correctly for data management activities.
    • Collaboration:
      Work closely with other project team members to ensure smooth data management processes and meet project timelines. Participate in team meetings and assist with ongoing project deliverables.
    • Study Reports & Documentation:
      Run study status reports for sponsor meetings and specific sponsor requests. Maintain project documentation, including eTMF and other data management-related administrative tasks.
    • Database Lock & Unlock Activities:
      Support the completion of database lock and unlock activities, ensuring accurate and timely data delivery.
    • Training & Mentorship:
      Assist in training new staff members on project-specific data management processes, ensuring compliance with established protocols and best practices.
    • Additional Duties:
      Perform other duties as assigned to support the success of the clinical data management team and the overall project goals.

    Qualifications:

    Education & Experience:

    • Required:
      • University or college degree or equivalent relevant experience.
      • Minimum 1-2 years of experience in clinical data management, data review, or a similar role in clinical trials.
      • Familiarity with clinical trial processes, data management systems, and the generation/resolution of data queries.

    Skills & Competencies:

    • Data Management Knowledge:
      Strong understanding of clinical data management processes, data review, and query resolution.
    • Technical Proficiency:
      Experience with clinical data management tools, eCRF, and SAS reporting tools is an advantage.
    • Attention to Detail:
      Excellent attention to detail, with the ability to identify, resolve, and track data issues efficiently.
    • Communication:
      Strong written and verbal communication skills to collaborate effectively with cross-functional teams.
    • Organizational Skills:
      Ability to manage multiple tasks and meet deadlines in a fast-paced environment.
    • Team Collaboration:
      Ability to work in a team environment, supporting peers and contributing to the overall success of the project.

    Why Fortrea?

    At Fortrea, we offer an inclusive and innovative work environment where your contributions will directly impact the success of clinical trials and the development of life-saving therapies. Join a global team that is passionate about advancing science and improving patient outcomes.

    Fortrea is an Equal Opportunity Employer:
    We are committed to fostering a diverse and inclusive workforce. Fortrea does not tolerate harassment or discrimination of any kind and makes employment decisions based on business needs and individual qualifications.

    For more information about Fortrea and to apply, visit www.fortrea.com.

    Application Deadline:
    Applications will be accepted on a rolling basis until the position is filled.

    For more details on how we collect and store your personal data, please review our Privacy Statement.

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