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    Clinical Scientific Expert I

    Novartis
    1+ years
    Not Disclosed
    Hyderabad
    10 June 27, 2024
    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, 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 Summary

    Position: Clinical Scientific Expert
    Location: Hyderabad, India
    Company / Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
    Division: Development
    Business Unit: Innovative Medicines
    Functional Area: Research & Development
    Job Type: Full-time
    Employment Type: Regular
    Shift Work: No

    Join the Global Drug Development (GDD) team at Novartis, where 150 clinical scientific experts globally work to ensure the highest quality of clinical trial data and regulatory reports throughout the life cycle of each program across all disease areas. Be part of a dedicated, passionate team providing clinical and scientific inputs at the study and program level, supporting Novartis in reimagining medicine for patients worldwide.

    Major Accountabilities

    • Clinical Data Review: Ensure high-quality clinical trial data review, insights, and analysis as directed by the Integrated Clinical Trial Team (iCTT).
    • Data Analysis: Perform high-quality clinical data review, identify clinical data insights through patient-level review and trends analysis, and facilitate resolution of clinical data issues.
    • Data Review Plan: Contribute to the development of the Data Review/Quality Plan (DRP/DQP) and data review strategy.
    • Protocol Implementation: Ensure consistent implementation of protocol-level deviations, eligibility criteria, and study assessments across the study.
    • Case Report Form Development: Contribute to Case Report Form (CRF) development and support the implementation of data capture tools.
    • Process Improvements: Facilitate data review process improvements and implement innovative data analysis processes and tools.
    • Regulatory Documents: Contribute to the development of study-level documents, including clinical sections of key regulatory documents, and review/write clinical trial documents for CSR activities and publications.
    • Pharmacovigilance Support: Support pharmacovigilance activities, including reviewing/contributing to aggregate reports and attending Safety Monitoring Meetings (SMT).
    • Training: Produce training materials and provide training to iCTT.

    Minimum Requirements

    • Educational Qualification: Advanced degree in life sciences/healthcare (e.g., Master's, PharmD, M.Pharma, PhD, MBBS, BDS, MD). Fluent in English (oral and written).
    • Experience: Over 1 year of experience in the pharmaceutical industry/clinical research organization with basic knowledge in planning, executing, reporting, and publishing global clinical studies.
    • Work Experience: Preferably in clinical operations.
    • Skills: Strong interpersonal, negotiation, conflict resolution, and communication skills. Ability to work under pressure and collaborate across boundaries. Knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development. Strong analytical/computational background and medical/scientific writing skills. Demonstrates knowledge and application of statistical analysis methodology.

    Why Novartis?

    In 2021, Novartis medicines touched 766 million lives. We strive to improve and extend lives by combining medical science with digital innovation in a diverse, equitable, and inclusive environment. Our unbossed culture, underpinned by integrity, curiosity, and flexibility, allows us to tackle the world’s toughest medical challenges. Imagine what you could do at Novartis!

    Join our Novartis Network: If this role does not suit your experience or career goals, join our talent community to stay connected and learn about suitable career opportunities: Join the Novartis Network.

    Learn More About Novartis: Our Strategy, People, and Culture.

    Novartis Commitment to Diversity:

    Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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