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.
Good 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
Additional Information
Travel: 0%
Location: India, Bangalore
Don’t meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
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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