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    Clinical Data Analyst I

    Parexel
    1-3 years
    Preffered by Company
    Bangalore
    10 Sept. 3, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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

    Position: Clinical Data Analyst I

    Role Overview:

    The Clinical Data Analyst I (CDA I) supports clinical data cleaning activities and data management tasks under the guidance of their Line Manager and/or Subject Matter Experts. This entry-level role involves assisting with data validation, processing activities, and data management documentation. The CDA I will contribute to ensuring data quality and compliance with corporate standards, SOPs, ICH-GCP, and other international regulatory requirements.

    Key Responsibilities:

    1. Data Validation and Cleaning:

      • Assist in data cleaning and review activities, including query management and manual/SAS listing reviews.
      • Support data processing tasks from database setup through to database lock, including external vendor data reconciliation.

    2. Data Management Documentation and Plans:

      • Help with the setup and maintenance of data management documents, ensuring documentation is accurate and compliant with SOPs and ICH/GCP guidelines.

    3. Study Start-Up and User Acceptance Testing (UAT):

      • Begin to lead user acceptance testing for clinical database setups.
      • Review study protocols and Electronic Data Capture (EDC) entry screens if necessary.

    4. Data Tracking and Entry:

      • Track and review Case Report Forms (CRFs) and support data entry as needed.

    5. Project Quality Management and Compliance:

      • Ensure compliance with SOPs and ICH/GCP guidelines.
      • Support or lead quality control activities on databases and patient data as required.

    6. Training:

      • Maintain training compliance for assigned job roles, including on-the-job training.
      • Address training needs based on development goals and provide support to other team members as needed.

    Skills:

    • Strong problem-solving skills and logical reasoning.
    • Commitment to high-quality work with attention to detail.
    • Effective time management and prioritization to meet deadlines.
    • Ability to work collaboratively within a team environment.
    • Good interpersonal, oral, and written communication skills.
    • Rapid learning ability with a knowledge-sharing approach.
    • Flexibility and adaptability to changing technical environments.
    • Accountability and adherence to job responsibilities.
    • Fluent in written and spoken English.

    Knowledge and Experience:

    • Demonstrates technical aptitude with experience in Microsoft Office Products.
    • Basic understanding of data management processes and validation flow (e.g., data cleaning, database lock).
    • Familiarity with ICH-GCP guidelines, local regulatory requirements, and relevant SOPs.
    • 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).
    • Basic knowledge of data management processes during study start-up, conduct, and close-out.
    • Familiarity with database setup activities, including Database Configuration Specifications and data validation.

    Education:

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

    Location:

    • Office-based in Bengaluru, Hyderabad, or Mohali.

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