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    Associate Director Data Ops & Analytics, Rdq

    Novartis
    5+ years
    Not Disclosed
    Bangalore
    10 Sept. 13, 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, 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:

    Associate Director, Data Operations & Analytics RDQ

    Division: Development

    Business Unit: Innovative Medicines

    Location: Hyderabad, India (Office)

    Company / Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited

    Functional Area: Quality

    Job Type: Full-time

    Employment Type: Regular

    Summary

    As the Associate Director of Data Operations & Analytics in Research & Development Quality (RDQ), you will play a critical role in ensuring that clinical data management, database development, statistical programming, and analytics processes meet Novartis standards, Health Authority regulations, and Good Clinical Practice (GCP) guidelines. You will provide expertise and guidance to ensure the integrity and effectiveness of clinical data processes and collaborate with business and quality teams to identify and mitigate potential quality risks.

    About the Role

    Key Responsibilities:

    • Quality Oversight:

      • Provide quality advice and oversight for the entire data flow and analysis process, including study development, electronic data capture, statistical analysis, and clinical study report creation.
      • Ensure compliance with Novartis standards, Health Authorities regulations, and GCP guidelines throughout the data management lifecycle.

    • Audit and Compliance Support:

      • Assist business functions during audit and inspection preparations, respond to audit requests, and help create Corrective and Preventive Actions (CAPAs).

    • Digital and Technological Integration:

      • Collaborate across business units to embed and implement digital capabilities, data science, and new technologies into drug development and clinical trial processes.

    • Strategic Collaboration:

      • Work with various functions (e.g., Business Franchises, Global Data Operations, Pharmacovigilance, IT) to develop strategies for a capable and empowered data operations organization.
      • Ensure alignment with internal and external stakeholders.

    • Documentation and Process Improvement:

      • Support the development and maintenance of quality documents, such as guidelines and SOPs, to ensure they are fit for purpose and compliant with relevant regulations.
      • Assist in risk assessments for new processes and technologies.

    • Consultancy and Risk Management:

      • Provide consultancy for Integration and Due Diligence activities linked to Business Development and Licensing (BD&L).
      • Proactively identify and mitigate regulatory, quality, and compliance risks and apply Clinical Trial Quality Risk Management concepts.

    • Cross-Functional Projects:

      • Contribute to cross-functional projects to continuously improve Novartis standards and processes.
      • Engage in regulatory consultations and share insights to enhance process adherence and simplify operations.

    • Training and Capability Building:

      • Foster a collaborative culture by delivering training, sharing lessons learned, and engaging in regular meetings with internal and external partners.

    Essential Requirements:

    • Over 10 years of experience in the pharmaceutical industry or public health sector, focusing on Quality, Information Technology, Data & Digital, or Clinical Development.
    • Strong background in GCP, Pharmacovigilance, and other relevant Health Authority regulations, with knowledge of CSV, Part 11 requirements, and privacy and information security regulations.
    • Excellent interpersonal skills, demonstrating Novartis values of collaboration, quality, and integrity.
    • Ability to solve problems flexibly and provide strategic direction.
    • High learning agility, comfortable with complexity, and committed to continuous improvement.
    • Effective communication skills across various organizational levels.
    • Proven ability to build strong relationships with internal and external partners.
    • Experience in change management to support high ethical standards and compliance.

    Desirable Requirements:

    • Bachelor’s degree in Life Sciences, Statistics, Information Technology, or related fields; Master’s degree or equivalent is a plus.

    Why Novartis? At Novartis, our mission is to reimagine medicine to improve and extend people’s lives. Our vision is to become the most valued and trusted medicines company globally. Join us in this mission and be part of a community that drives innovation and achieves breakthroughs in patient care.

    Benefits and Rewards: Explore our comprehensive benefits and rewards in the Novartis Life Handbook: Novartis Benefits & Rewards.

    Join Our Network: If this role isn’t a perfect match for you, but you’re interested in future opportunities, join the Novartis Network: Novartis Talent Network.

    Commitment to Diversity and Inclusion: Novartis is dedicated to creating an inclusive environment that reflects the diversity of the patients and communities we serve.

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