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    Senior Clinical Data Analyst

    Parexel
    2+ years
    Not Disclosed
    Bangalore
    10 March 19, 2025
    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: Senior Clinical Data Analyst (SCDA)
    Company: [Insert Company Name]
    Location: [Insert Location]
    Job Type: [Full-time/Contract]

    About This Role:
    The Senior Clinical Data Analyst (SCDA) plays a pivotal role in leading and coordinating clinical data validation activities on assigned projects with a high level of proficiency and autonomy. The SCDA provides technical expertise and operational leadership regarding all Data Management (DM) activities, including data validation, query management, and database lock processes. The role ensures adherence to corporate quality standards, SOPs, ICH-GCP guidelines, and other regulatory requirements. The SCDA serves as a subject matter expert on DM systems and processes and provides expert advice to internal and external sponsors. Additionally, the SCDA may step into the Data Management Lead role when required.

    Key Responsibilities:

    • Lead Data Validation: Oversee data cleaning, review, and reconciliation activities during study conduct and database lock, including query management and external vendor data reconciliation.
    • System and Process Expertise: Serve as a subject matter expert for DM systems, providing technical support and advice on data management processes, including data validation flow, database setup, and configuration.
    • Operational Leadership: Coordinate DM operational activities during database setup, from project initiation to closeout, ensuring adherence to timelines and quality standards.
    • User Acceptance Testing (UAT): Lead or support UAT on clinical database setups and provide input for system configurations.
    • Develop Tools for Efficiency: Improve and implement project-specific tools and resources to enhance the efficiency of data management tasks, including status reports and standardized directories.
    • Sponsor Liaison: Interact with sponsor teams to discuss data issues and validation requirements, ensuring smooth communication and issue resolution.
    • Collaboration and Leadership: Work with cross-functional and global teams, leading the coordination and prioritization of tasks, and influencing decisions to achieve project objectives.
    • Quality Focus: Ensure first-time quality in data validation processes, applying methodical, analytical, and detail-oriented approaches to tasks.
    • Training and Knowledge Sharing: Mentor junior team members and share expertise to improve team capabilities and project performance.
    • Financial Awareness: Contribute to budget reviews and resource forecasts, ensuring efficient financial management of data management tasks.

    Skills & Qualifications:

    • Proven Leadership: Ability to lead and collaborate with global teams, coordinating tasks for data management and programming teams.
    • Problem-Solving Expertise: Strong analytical skills, capable of making decisions in ambiguous situations and conducting root cause analyses.
    • Communication: Advanced verbal and written communication skills with a diplomatic approach, including good presentation abilities.
    • Flexibility & Adaptability: Ability to adjust quickly to new technologies, processes, and work assignments.
    • Time Management: Proven ability to prioritize tasks and manage time effectively to meet objectives within set deadlines.
    • Data Management Systems Proficiency: Advanced knowledge of clinical data management systems (e.g., InForm, Rave, Veeva, DataLabs, ClinBase).
    • Knowledge of Clinical Processes: Strong understanding of ICH-GCP guidelines, regulatory requirements, and clinical study team roles.
    • Medical Terminology: Advanced knowledge of medical terminology and coding dictionaries (e.g., MedDRA, WHODRUG).
    • SAS & Data Standards Knowledge: Basic understanding of SAS programming and CDISC data standards.
    • Financial Acumen: Familiarity with the financial management of data management projects, including forecasting and scope of work.

    Knowledge & Experience:

    • 5+ years of experience in clinical data management or clinical research industry.
    • Strong understanding of data management operational processes during study start-up, conduct, and close-out.
    • In-depth knowledge of database setup, data validation activities, and DM project financial management.

    Education:

    • Bachelor's degree in Life Sciences, Clinical Research, or a related field. Advanced degrees are a plus.

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