Lilly Global Operations - Data Management in Greenfield, Indiana
Type of Employment:
Full-Time Employment - FTE
Strategically achieve global clinical data management 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 and will also include unstructured data (e.g. media or video). This position will lead the development of best in class data managment process and capabilities within global Elanco as well as develop and direct third party relationships. This position is expected to be highly influential in partnering with product development teams to develop data management strategies that result in on-target delivery of final databases. This position will closely collaborate with R&D functions including biostatistics, regulatory affairs, and quality assurance to ensure data integrity, data quality, validation and compliance.
Functions, Duties, Tasks:
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.
Lead the delivery of innovative technical solutions and create an innovative culture.
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
Lead and deploy global data management strategies surrounding data capture, management, reporting, storage and archival.
Expertise in deployment, validation, testing and implementation of electronic data capture systems as part of data management strategies
Ensuring data integrity from database development, through collection, storage and archiving
Data management leader for preparation and implementation of data management planning across global R&D project teams from initiation to completion
Coordinate resources and capabilities both internally and externally to achieve R&D target objectives.
Ensure adherence to clinical data collection policies and procedures; lead continuous transformation to keep Elanco at the forefront of standards for the animal health industry
Train and educate R&D functions, including project teams, biostats, regulatory affairs and quality assurance on data collection systems, processes and best practices
Confirm validation and compliance to all regulations (including GxP) and guidelines of the global data management systems and processes utilized to collect, manage, report, store and archive databases containing clinical data
Bachelor's Degree in Information Technology, statistics or scientific field related to animal health
Minimum (3) years experience in working directly in data management with animal health experience
Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Working knowledge of EDC systems/capabilities and their application across regulatory standards (GXP and non-GXP) in animal health R&D
Demonstrated leadership skills and ability to work within and lead interdisciplinary teams
Clinical trial experience
Advanced knowledge of electronic data capture systems
Experience interacting with third party organizations
Experience interacting with regulatory authorities
This position will be based in the Greenfield IN, but may be eligible for remote locations within the continental United States
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.
Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we’re driven by our vision of food and companionship enriching life – all to advance the health of animals, people and the planet. Learn more at www.elanco.com
Region: North America
Req Id: 50924BR