Consultant- Clinical Operations at Elanco in Bengaluru, Karnataka, IN

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. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

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!

Your role: Consultant Clinical Operations

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 leadership position is expected to be highly influential in partnering with product development teams, internal sites, 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. This position will also provide leadership and management of DM activities for clinical projects and internal sites.

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.
• Provide and accept challenges 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
• Educate, represent, and advocate for DM policies and procedures with internal and external stakeholders
• Coach and mentor DM colleagues, contribute to their knowledge of the animal drug development field.
• 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), guidelines, global data management systems, and process utilized to collect, manage, report, store and archive databases containing clinical data
• Maintain DM project timelines, assure they are met
• Site/project level interactions and rapport building with all key stakeholders.
• Review and monitor the workload including forecast at the site/project level.
• Point of contact (POC) for all the DM activities for the assigned site/project
• Drive standardization at the site/project and department level
• Author as appropriate, review and provide inputs to all the data management documents (DMP, Project plan, UAT log, EFPs, Training Documents, etc)
• Facilitate communication to Global DM team members as appropriate (may lead to regular team meetings including the Lead DM)
• Function as liaison for sites/project teams, represent and address their needs within DM general business processes
• Additional responsibilities as assigned

What You Need to Succeed (minimum qualifications):

• BS or equivalent in IT, statistics or scientific field related to animal health, or relevant work experience in the animal drug development industry
• 10 or >10 years of Experience working in a global network or supporting a global network, specifically in animal health R&D
• Thorough knowledge of electronic systems and capabilities and their application in animal/ health R&D, maintenance validation and data pulls are a plus
• Demonstrated leadership skills and ability to work within and across interdisciplinary teams.

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

• Clinical trial experience and/or clinical trial data experience
• Advanced knowledge of electronic data capture systems
• Experience interacting with regulatory authorities and regulatory submissions.
• Project Management and/or development of QMS experience

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