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    Clinical Data Svs Analyst

    Accenture
    3-5 years
    Not Disclosed
    Bangalore
    10 Aug. 14, 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 Title: Clinical Data Services Analyst

    Skill Required: Clinical eTMF Management

    Qualifications: Bachelor’s or Master’s in Pharmacy

    Experience: 3 to 5 years

    About Accenture:

    Accenture is a global professional services company with leading capabilities in digital, cloud, and security. We combine unmatched experience and specialized skills across more than 40 industries, offering Strategy and Consulting, Technology and Operations services, and Accenture Song. Our 699,000 employees serve clients in over 120 countries, creating value through technology and human ingenuity. Learn more at www.accenture.com.

    Role Overview:

    As a Clinical Data Services Analyst, you will be part of our Life Sciences R&D vertical, specializing in Clinical eTMF (electronic Trial Master File) Management. Your role will involve managing clinical data through various stages of clinical trials, ensuring data quality, accuracy, and compliance. You will be responsible for performing data management activities, including discrepancy review, query generation, and resolution, as well as handling protocol deviations and database validation.

    Key Responsibilities:

    • Data Management: Perform activities such as discrepancy review, query generation, and resolution.
    • Documentation: Create CRF Completion Guidelines (CCG) and SAE reconciliation guidelines, and manage essential document reconciliation.
    • Database Validation: Conduct edit check validation, write test scripts, and perform User Acceptance Testing (UAT) against CRF/ECRF.
    • Project Management: Manage clinical data management projects and ensure data integrity throughout the clinical trial lifecycle.
    • eTMF Oversight: Review and ensure accuracy of the Trial Master File (TMF) contents, including protocol packages, amended checklists, and clinical study report appendices.

    Qualifications and Skills:

    • Education: Bachelor’s or Master’s in Pharmacy.
    • Experience: 3 to 5 years in clinical data management or related field.
    • Skills:
      • Clinical eTMF Management.
      • Adaptability and flexibility.
      • Ability to perform under pressure.
      • Problem-solving skills and detail orientation.
      • Ability to establish strong client relationships.

    Working Conditions:

    • Interaction: Daily interactions with peers within Accenture, with moderate exposure to supervisors and limited client interaction.
    • Instructions: Receive moderate-level instructions for daily tasks and detailed guidance for new assignments.
    • Decision-Making: Decisions impact your own work and may affect others.
    • Scope: Individual contributor role with a focused scope of work.
    • Shifts: May require working in rotational shifts.

    If you are a detail-oriented professional with a strong background in clinical data management and are passionate about ensuring the accuracy and integrity of clinical trials, we encourage you to apply and join our dynamic team at Accenture.

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