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Associate Director Data Ops & Analytics, Rdq

1-3 years
Not Disclosed
10 Aug. 22, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

Summary

As the Associate Director of Data Operations & Analytics in Research & Development Quality (RDQ), you will play a crucial role in supporting key R&D processes related to Database Development, Data Management, Statistical Programming, and Analytics. Your primary responsibility is to ensure that clinical data management and analysis processes align with Novartis standards, Health Authority regulations, and GCP guidelines. You will work closely with business and quality teams to identify and mitigate potential quality risks, ensuring that all data-related activities are fit for purpose.

About the Role

Position: Associate Director Data Operations & Analytics RDQ
Location: Hyderabad, India
Division: Development
Business Unit: Innovative Medicines
Company: Novartis Healthcare Private Limited
Employment Type: Full-time, Regular

Key Responsibilities:

  • Quality Oversight: Provide expert guidance to ensure compliance with standards and regulations throughout the data flow and analysis processes, including electronic data capture systems, statistical analysis, and clinical study report development.
  • Audit Support: Assist business functions in preparing for audits and inspections, responding to requests, and creating Corrective and Preventive Actions (CAPAs).
  • Digital Integration: Collaborate across business units to integrate digital capabilities, data science, and new technologies into clinical trial processes.
  • Process Improvement: Support the development and implementation of quality documents, ensuring they meet Novartis standards and regulatory requirements.
  • Risk Management: Identify and mitigate regulatory, quality, and compliance risks, applying Clinical Trial Quality Risk Management concepts as needed.
  • Consultancy: Provide consultancy on Integration and Due Diligence activities related to Business Development and Licensing.
  • Training and Collaboration: Foster a culture of continuous improvement by delivering educational materials, sharing lessons learned, and collaborating with internal and external partners.

Essential Requirements:

  • Experience: Over 10 years of relevant experience in the pharmaceutical industry or public health sector, with a strong background in GCP, PV, and other Health Authority regulations.
  • Skills: Expertise in CSV, Part 11 requirements, and information security regulations. Strong interpersonal skills, problem-solving abilities, and the capacity to innovate.
  • Education: Bachelor’s degree in Life Sciences, Statistics, Information Technology, or related fields. A Master’s degree or equivalent is preferred.
  • Communication: Excellent ability to communicate across various audiences and organizational levels, with a high awareness of industry trends and external demands.

Desirable Skills:

  • Proven track record in change management, building effective relationships, and sustaining a culture of high ethical standards and compliance.
  • High learning agility and a strong interest in continuous improvement.

Why Novartis?

At Novartis, our mission is to reimagine medicine to improve and extend people's lives. We believe that our success relies on the talent and dedication of our associates. By joining us, you become part of a team that strives to achieve breakthroughs in patient care and drive innovation in the pharmaceutical industry.

Benefits and Rewards:

Discover our comprehensive benefits and rewards in the Novartis Life Handbook: Novartis Life Handbook

Join Our Network:

If this role isn’t the right fit for you but you want to stay updated on future opportunities, join the Novartis Network: Novartis Network

Ready to Make a Difference?

Be part of a community that values collaboration, innovation, and integrity. Together, we can achieve great things and make a real impact on patients' lives.

For more information about our vision and strategy, visit Novartis Strategy.