Senior Associate-Clinical Operations

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Key Leadership Responsibilities

• Proactively search for solutions.
• Work effectively and flexibly within and across all Elanco R&D teams and external
  
  

collaborators to achieve overall Elanco R&D deliverables.

• Create a positive work environment that is aligned with company objectives.
• Create an engaging culture with a "Play to Win” mentality.
• Identify and utilize methods to deliver individual objectives in a high quality, timely, cost-
  
  

effective manner.

• Demonstrate high levels of adaptability, flexibility, and learning agility.
  
  

Key Technical Responsibilities

• Expertise in deployment, validation, testing and implementation of electronic data capture
  
  

systems as part of data management strategies.

• Responsible for number of activities related to Design, Development and maintenance of
  
  

Clinical Data Base.

• Maintenance of Case report forms, Database objects, Forms, Edit checks and procedures.
• Copy/Create study database objects such as DCM’s, DCI’s, DCI books, Forms, Edit-
  
  

checks and procedures from the global library and customize as per specification while

ensuring consistency in databases.

• Performing self-testing for the database objects.
• Copy and customize non-standard objects and programs from the Global Library, as
  
  

applicable.

• Build non-standard objects from scratch and ensure they are aligned to specifications, as
  
  

applicable.

• Provide user support, troubleshooting and maintenance of the tools and documentation
  
  

related to these activities, as needed.

• Perform annotation / database update / quality assurance on case report form (CRF)
  
  

annotations for post-production study changes as applicable.

• Participate in UAT when new application release occurs, as applicable.
• Assemble database components (Forms, Folders, Matrices, Layouts, Derivations,
  
  

Validations, Edit Checks and Custom Functions) as per the specifications.

• Migrate database, as needed.
• Perform quality assurance on DBD internal audit process in Electronic Trial Master File tool, as and when needed.
• Define scope and conduct impact analysis for migrations and post-production changes, as required.
• Perform Migrations and Post productions changes as needed.
• Generate and provide Annotated and Non-Annotated case report forms, as needed.
• Configure Coder module, as required.
• Coordinate resources and capabilities both internally and externally to achieve R&D target objectives.
• Ensure adherence to clinical data collection policies and procedures and is expected to keep Elanco at the forefront of standards for the animal health industry.
• Confirm validation and compliance to all regulations (including GxP) and guidelines the global data management systems and process utilized to collect, manage, report, store and archive databases containing clinical data.
• In collaboration with global DM members, contribute to development and review of SOPs, QMS documents and process documents.
• Serve as the primary technical expert for complex post-production changes and database migrations, defining scope and conducting impact analysis.
• Lead the development, maintenance, and governance of the Global Library of database objects, driving standardization and efficiency.
• Coach, mentor, and provide technical guidance to junior database programmers, reviewing their work and fostering their professional growth.
  
  

Minimum Qualification (education, Experience And/or Training, Requi

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

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