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    Clinical Data Analyst I

    Parexel
    2+ years
    Not Disclosed
    Remote
    10 Oct. 7, 2024
    Job Description
    Job Type: 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

    About This Role

    Job Purpose:

    The Clinical Data Analyst I (CDA I) works under the guidance of their Line Manager and/or Subject Matter Experts to perform clinical data cleaning activities on assigned projects, in line with their experience and project role. Key responsibilities include supporting data processing activities and managing Data Management documents and data cleaning matrices (e.g., Data Validation Specifications, CRF Completion Guidelines, Protocol Deviation Specifications, Mock Shells for Off-line Listings). All tasks must adhere to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP, and other international regulatory requirements.

    Key Accountabilities:

    Data Validation (Cleaning)

    • Take responsibility for or lead data cleaning and review activities (Co-Primary CDA/Primary CDA), including query management and manual/SAS listing reviews.
    • Support or begin leading data processing activities from database setup to database lock, including external vendor data reconciliation.

    Data Management Documents/Plans (Trial Master File)

    • Perform and support the setup of DM documents, ensuring proper documentation as per Standard Operating Procedures and ICH/GCP Guidelines.

    Study Start-Up Activities and User Acceptance Testing (UAT)

    • Begin leading or performing user acceptance testing on clinical database setups.
    • Review protocols and EDC Entry Screens as needed.

    Data Tracking and Entry

    • Track and review CRFs, supporting data entry as required.

    Project Quality Management & Compliance

    • Ensure compliance with Standard Operating Procedures and ICH/GCP Guidelines.
    • Support or start leading functional quality control activities on databases and/or patient data as business needs dictate.

    Training

    • Maintain training compliance as per assigned job roles, including on-the-job training.
    • Address training needs based on identified Development Goals.

    Skills:

    • Strong problem-solving skills and logical reasoning.
    • Commitment to first-time quality, demonstrating a methodical, analytical, and accurate approach to work (attention to detail).
    • Effective time management and prioritization skills to meet objectives and timelines.
    • Ability to collaborate effectively within a team environment.
    • Good interpersonal, oral, and written communication skills.
    • Quick learning ability and a knowledge-sharing approach; adaptability to new technologies and processes.
    • Flexible attitude towards work assignments and learning opportunities; ability to adjust rapidly to changing technical environments.
    • Accountability regarding key responsibilities outlined in the job description.
    • Proficiency in written and oral English.

    Knowledge and Experience:

    • Technical aptitude with basic knowledge of Microsoft Office Products.
    • Basic understanding of data management processes and data validation flows (e.g., data cleaning, database lock).
    • Familiarity with ICH-GCP Guidelines, local regulatory requirements, and Parexel SOPs and study-specific procedures.
    • Basic knowledge of Clinical Data Management Systems (e.g., InForm, Rave, Veeva, Datalabs, ClinBase).
    • Understanding of Clinical Study Team roles within Data Management.
    • Experience in the clinical research industry.
    • Basic knowledge of medical terminology and coding dictionaries (e.g., MedDRA & WHODRUG).
    • Familiarity with Data Management operational processes and tasks during study start-up, conduct, and close-out.
    • Basic understanding of database setup activities, including Database Configuration Specifications and Data Validation setup.

    Education:

    • Bachelor’s degree and/or relevant medical qualifications or industry experience.

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