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    Clinical Data Specialist

    Novartis
    2-8 years
    Not Disclosed
    Hyderabad
    14 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

    Contribute, under appropriate supervision, to all facets of global clinical trials to achieve study outcomes within predetermined schedules, budgets, quality/compliance standards, and performance metrics. This role may involve leading specific components of global clinical trials and serves as a core member of the Clinical Trial Team, fostering operational excellence through process enhancement and knowledge exchange.

    About the Role

    Major Accountabilities:

    1. Contribute to all operational and clinical trial deliverables within the scope of the job description, ensuring adherence to timelines, budgets, operational protocols, and quality/compliance benchmarks.
    2. Participate in study start-up activities, including overseeing protocol, CRF, and Informed Consent Form development.
    3. Evaluate potential clinical trial sites, assess capabilities, and provide recommendations for trial inclusion.
    4. Oversee all aspects of study conduct and closeout activities, including site closures, final drug accountability, and Trial Master File documentation audit readiness.
    5. Facilitate education, implementation, and compliance with standards (SOPs) and best practices for clinical operations and data review activities within assigned trials and clinical programs.
    6. Promptly report technical complaints, adverse events, and special case scenarios related to Novartis products.

    Key Performance Indicators:

    1. Timely, efficient, and high-quality execution of assigned trials and related activities within budgetary constraints and in compliance with quality standards.
    2. Proactive operational planning, including effective contingency and risk mitigation strategies.
    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 principles.
    • Ability to collaborate across organizational 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.

    Novartis is dedicated to fostering an inclusive work environment and diverse teams that reflect the patients and communities they serve. If you’re passionate about making a difference, join the Novartis Network to stay informed about career opportunities: Talent Community Sign-up.

     

     

     

     

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