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!
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Position Description: Strategically achieve global clinical data management objectives through systems and processes used during data capture, management, reporting, storage and archival. This will include electronic data and may include paper data collection process and systems. This position is expected to be highly influential in partnering with product development teams and third parties to develop data management strategies that result in on-target delivery of final databases. This position will closely collaborate with R&D functions including clinical development, internal study sites, biostatistics, regulatory affairs, and quality assurance to ensure data integrity, data quality, validation, and compliance.
Incumbent will function as supervisor to a team of DM personnel with oversight for LMS training, day-to-day work assignments, process development and oversight of process execution in support of regulatory submissions, and other day-to-day activities as assigned. In addition, incumbent is expected to perform key leadership responsibilities which provide innovative solutions, a positive and motivating work environment, and ultimately deliver the Elanco pipeline.
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.
- Provide and accept challenge to deliver 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
- Provide expertise in deployment, validation, testing and implementation of electronic data capture systems as part of data management strategies.
- Responsible for preparation and implementation of study data management plans across 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 and is expected to keep Elanco at the forefront of standards for the animal health industry
- Train and educate R&D functions, including project teams, biostatistics, regulatory affairs and quality assurance on data collection systems, processes and best practices
- 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
- Perform sample QC for the work done by the junior team members (for pivotal studies)
Key Management Responsibilities
- Incumbent will provide day-to-day supervision of team including:
- Collaboration with other managers and team members in Clinical Development and Project Team to ensure strategic and coordinated team approach/involvement with the development of study protocols and DM deliverables. Includes the appropriate assignment and prioritization of study activities/responsibilities within the team.
- Lead by example through consistently demonstrating high performance with regard to lead DM responsibilities.
- Oversee LMS training and personal development of direct reports related to their position responsibilities/accountabilities, regulatory compliance requirements, position specific technical training, and competency/skill development.
- Work with management to develop team Essential Wins, optimally utilize resources, provide personal development opportunities to team members, and report key activities and metrics.
- Monitor and plan the team utilization.
Minimum Qualification (education, experience and/or training, required certifications):
- BS or equivalent in IT, statistics or scientific field related to animal/human health, or relevant work experience in the animal health industry
- 10 or >10 Experience working in a global network or supporting a global network, specifically in animal/human health R&D
- Thorough 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/or clinical trial data experience
- Experience of people leader role with managing team
- 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
