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!
Position Title:
Study Build Programmer
Supervisor Title:
Director – Global Data Management
Position Type:
Full Time
Job Function:
Programmer – Study Build
Location:
Office
Position Description:
Execute global clinical data management in Animal Health through systems and processes used for data capture, management, reporting, storage and archival. This will include structured paper and electronic data collection process and systems from clinical trials conducted in farm and pet animals.
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.
Key Leadership Responsibilities
- Proactively search for solutions.anianima
- 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 database.
- 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.
- Create and maintain global library user guide, as needed.
- 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.
Minimum Qualification (education, experience and/or training, required certifications):
- BS or equivalent in IT, statistics or scientific field related to animal health/human health, or relevant work experience in the animal/human health industry.
- 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.
Additional Preferences:
- 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.
Other Information:
- This position will be based in Bangalore, India as outlined with local requirements.
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
