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    Clinical Data Specialist

    Novartis
    0-5 years
    Not Disclosed
    Hyderabad
    12 May 24, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Summary

    This role contributes, under appropriate supervision, to all aspects of global clinical trials, ensuring study outcomes are achieved within schedule, budget, quality/compliance, and performance standards. The incumbent may lead specific aspects of global clinical trials and serves as a core member of the Clinical Trial Team, fostering operational excellence through process improvement and knowledge sharing.

    About the Role

    Major Accountabilities:

    1. Contribute to all operational/clinical trial deliverables within the scope of the specific job description, adhering to timelines, budget, operational procedures, quality/compliance, and performance standards.
    2. Participate in or lead study start-up activities, including overseeing protocol development, CRF development, and Informed Consent Form development.
    3. Assess and recommend new sites for clinical trials, analyzing capability for trial inclusion.
    4. Ensure proper handling of all study conduct and closeout activities, including site closeout, final drug accountability, and audit readiness of Trial Master File documentation.
    5. Educate, implement, and ensure compliance with standards (SOPs) and best practices for clinical operations/clinical data review activities within assigned clinical trial(s) and programs, including sharing lessons learned.
    6. Report technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt and distribute marketing samples where applicable.

    Key Performance Indicators:

    1. Timely, efficient, and high-quality execution of assigned trials and trial-related activities within budget, and in compliance with quality standards.
    2. Proactive operational planning with effective contingency and risk mitigation plans.
    3. Adherence to Novartis policies, guidelines, and external regulations.

    Minimum Requirements:

    Work Experience:

    • Experience in Operations Management and Execution.
    • Proficiency in Project Management.
    • Knowledge of Financial Management.
    • Ability to collaborate across boundaries.

    Skills:

    • Proficiency in Trial Planning and Feasibility assessment.
    • Familiarity with Over The Counter Product Development.
    • Understanding of Post Authorization Data Safety.
    • Knowledge of Regulatory Strategy.
    • Competence in Clinical Trial Set-up, Management & Conduct.

    Languages:

    • Proficiency in English.

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