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    Clinical Data Analyst Ii

    Parexel
    0-5 years
    Preffered by Company
    Bangalore Hyderabad
    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 II

    Role Overview:

    The Clinical Data Analyst II (CDA II) is responsible for executing clinical data validation activities with minimal supervision. This role involves managing data validation processes, supporting data management documentation, and ensuring compliance with quality standards, SOPs, ICH-GCP, and other international regulations. The CDA II will also play a key role in data cleaning, database setup, and user acceptance testing, as well as providing training and mentoring to other team members.

    Key Responsibilities:

    1. Data Validation and Cleaning:

      • Lead data validation activities, including cleaning, review, and reconciliation during study conduct and database lock (Primary CDA).
      • Manage queries, perform manual and SAS listing reviews, and reconcile data from external vendors.

    2. Data Management Documentation and Plans:

      • Perform and support the creation and maintenance of data management documents, ensuring compliance with SOPs, ICH/GCP guidelines, and other regulatory requirements.
      • Support the setup of Data Management documents and maintain proper documentation in the Trial Master File.

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

      • Conduct user acceptance testing for clinical database setups.
      • Review study protocols and Electronic Data Capture (EDC) entry screens as needed.
      • Provide input on data management timelines and coordinate operational activities during database setup.
      • Track and review Case Report Forms (CRFs) and support data entry when necessary.

    4. Project Quality Management and Compliance:

      • Ensure adherence to SOPs, ICH/GCP guidelines, and other quality standards.
      • Perform and lead quality control activities on databases and patient data as required.

    5. Training and Development:

      • Maintain compliance with training requirements related to assigned job roles.
      • Address identified training needs and provide relevant on-the-job training to staff and project teams.
      • Mentor other clinical data analysts and support their development.

    Skills:

    • Strong problem-solving abilities and logical reasoning skills.
    • Detail-oriented with a methodical and analytical approach to work.
    • Effective time management and prioritization skills to meet deadlines.
    • Proven ability to work collaboratively within a team environment.
    • Capable of coordinating and prioritizing tasks, especially in the Primary CDA role.
    • Good interpersonal, oral, and written communication skills.
    • Rapid learning ability and a knowledge-sharing approach.
    • Flexibility and adaptability to changing technical environments.
    • Accountability and adherence to key job responsibilities.
    • Fluent in written and spoken English.

    Knowledge and Experience:

    • Strong technical aptitude with proficiency in Microsoft Office products.
    • Good understanding of data management processes and validation flow, including data cleaning and database lock.
    • Knowledge of ICH-GCP guidelines, local regulatory requirements, and relevant SOPs.
    • Familiarity with Clinical Data Management Systems (e.g., InForm, Rave, Veeva, DataLabs, ClinBase).
    • Understanding of Clinical Study Team roles in Data Management.
    • Experience in the clinical research industry.
    • Knowledge of medical terminology and coding dictionaries (e.g., MedDRA, WHODRUG).
    • Understanding of data management processes during study start-up, conduct, and close-out.
    • Basic knowledge of SAS programming for listings and data standards (CDISC).

    Education:

    • Bachelor’s degree in a relevant field or equivalent medical qualifications/industry experience.

    Location:

    • Office-based in Bengaluru or Hyderabad.

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