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    Senior Clinical Data Analyst

    Parexel
    7+ years
    Preffered by Company
    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: Senior Clinical Data Analyst

    Role Overview:

    The Senior Clinical Data Analyst (SCDA) is an experienced professional responsible for leading and coordinating clinical data validation activities with a high degree of proficiency and autonomy. With over 7 years of experience, the SCDA provides technical expertise and operational leadership for data management (DM) activities, including data cleaning, validation, and documentation. Acting as a subject matter expert, the SCDA offers technical support and expert advice to internal teams and external sponsors. The role may also involve acting as a backup or fulfilling the Data Management Lead role as required.

    Key Responsibilities:

    1. Data Validation and Cleaning:

      • Lead and oversee data validation activities, including data cleaning, review, and reconciliation during both the conduct phase and database lock.
      • Manage query resolutions, manual/SAS listing reviews, and external vendor data reconciliation.
      • Identify and highlight issues or risks to project delivery, supporting mitigation strategies as part of the Risk Management Plan.

    2. Data Management Documents and Plans:

      • Oversee the setup and maintenance of DM documents, ensuring compliance with SOPs and ICH/GCP guidelines.

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

      • Lead 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 DM operational activities throughout the project lifecycle.

    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 adherence to SOPs and ICH/GCP guidelines.
      • Perform or lead quality control activities on databases and patient data according to business needs.

    6. Training and Mentorship:

      • Maintain training compliance for assigned roles, including on-the-job training.
      • Address training needs based on development goals and provide relevant training to staff and project teams.
      • Act as a mentor for other clinical data analysts.

    7. Process and Project Improvement:

      • Develop and implement project-specific tools to improve efficiency, including standard project directories and status reports.

    8. Project Finance and Resource Support:

      • Analyze operations-related project variances based on DM metrics and labor hour reports.
      • Provide input on scope changes and resource needs.

    Skills:

    • Proven ability to lead and collaborate with global and cross-functional teams.
    • Experience interacting with sponsors to address data issues and validation requirements.
    • Strong negotiation skills and ability to influence outcomes for mutually beneficial results.
    • Excellent problem-solving skills, including root cause analysis and decision-making in ambiguous situations.
    • Commitment to high-quality work with meticulous attention to detail.
    • Advanced time management and prioritization skills with a strong sense of urgency.
    • Exceptional interpersonal, oral, and written communication skills, tailored for diverse audiences.
    • Effective presentation skills.
    • Ability to rapidly learn and adapt to new technologies and processes.
    • Innovative approach to defining strategies for efficiency improvements.
    • Strong sense of accountability and ownership of responsibilities.
    • Fluent in written and spoken English.

    Knowledge and Experience:

    • Advanced technical aptitude with strong proficiency in Microsoft Office Products.
    • In-depth understanding of data management processes and data validation flow.
    • Comprehensive knowledge of ICH-GCP guidelines, local regulatory requirements, and company SOPs.
    • Advanced knowledge of Clinical Data Management Systems (e.g., InForm, Rave, Veeva, DataLabs, ClinBase).
    • Awareness of Clinical Study Team roles and activities, including budget reviews and resource forecasting.
    • Extensive experience in the clinical research industry.
    • Advanced knowledge of medical terminology and coding dictionaries (e.g., MedDRA, WHODRUG).
    • Advanced understanding of Data Management operational processes, including study start-up, conduct, and close-out.
    • Proficiency in database setup activities, including Database Configuration Specifications and data validation.
    • Basic knowledge of SAS and data standards (CDISC).
    • Understanding of financial principles related to DM project financials and forecasting.
    • Proven experience in leading virtual/global DM operational teams.
    • Experience in the CRO industry is desirable.

    Location:

    • Office-based in Bengaluru or Hyderabad.

    Education:

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

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