Clinical Data Management Specialist

3 weeks ago


Bengaluru, Karnataka, India Elanco Full time

At Elanco, we're a global leader in animal health, dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. Our vision is 'Food and Companionship Enriching Life', and we approach sustainability through the Elanco Healthy Purpose, advancing the health of animals, people, the planet, and our enterprise.

We foster a diverse and inclusive work environment, valuing diversity as the driving force behind innovation, creativity, and business success. Here, you'll work with dynamic individuals, acquire new skills and experiences, and be part of a company that champions new ways of thinking.

We're committed to making animals' lives better, and that makes life better. Key responsibilities:

  1. Strategically achieve global clinical data management objectives through systems and processes used during data capture, management, reporting, storage, and archival.
  2. Partner with product development teams and third parties to develop data management strategies.
  3. Closely collaborate with R&D functions, including clinical development, internal study sites, biostatistics, regulatory affairs, and quality assurance, to ensure data integrity, quality, validation, and compliance.

Key technical responsibilities:

  1. Use SAS or other software to develop custom programming reports, helping in data cleaning activities.
  2. Ensure outputs meet quality standards and project requirements.
  3. Perform validation programming and resolve discrepancies or findings with project team members.

Requirements:

  • BSc/MSc in related fields.
  • Minimum 10 years of relevant experience, with some vaccine development experience a plus.
  • Expertise in SAS programming with basic and advanced certifications.
  • Strong GxP knowledge, particularly GLP, GCP, and GMP.

This position will be based in Bangalore, India, with local requirements.



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