Your Role: Senior Database Programmer

This position will support best in class data management process and capabilities within global Elanco. This position will closely collaborate with R&D; functions including project scientists, global data managers, biostatisticians, and members of quality assurance to ensure data integrity, data quality, validation and compliance.

Your 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
- 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

What You Need to Succeed (minimum qualifications):

- BS or equivalent in IT, statistics or scientific field related to animal health/human health
- Minimum 10 years of relevant work experience in the animal/human health industry. (some vaccine development experience will be a plus)
- Working knowledge of electronic systems and capabilities and their application in animal/human health R&D;, maintenance validation and data pulls are a plus.
- Demonstrated leadership skills and ability to work within and across interdisciplinary teams.
- Strong GxP knowledge, in particular GLP, GCP and GMP.
- Valuable written and verbal communication skills.
- Knowledge of electronic systems and capabilities and their application in animal/human health R&D;, maintenance validation and data pulls are a plus.

What will give you a competitive edge (preferred qualifications):

- Clinical trial experience and clinical trial data along with study build experience (Rave/Inform/Veeva/ Medrio or any other database used to collect clinical trial data)
- Advanced knowledge of electronic data capture systems
- Experience interacting with regulatory authorities and regulatory submissions
- Ability to communicate logically and technically. Deliver all communication with clarity, impact and passion tailored to the audience.
- Organizational planning skills, ability to manage competing priorities and flexibility to change
- Commitment to quality
- Ability to work independently or as part of a team
- High competency in Microsoft Office
- Ability to work additional hours as required and work with staff in irregular time zones
- Ability to learn new systems and functions in an evolving technical environment

📌 Senior Clinical Programmer (Bengaluru)
🏢 Elanco Innovation And Alliance Centre
📍 Bengaluru