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: Senior Associate-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 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.
Your Responsibilities: -
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
Support deployment, validation, testing and implementation of electronic data capture systems as part of data management strategies.
Support preparation and implementation of study data management plans across R&D project teams from initiation to completion
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
Be part of the regular connects with site lead and study team (Site/Study program leads).
Perform all the DM activities, including data entry, verification, data cleaning activities
Support the UAT activities on the studies assigned
Perform the TMF filling activities completed at regular intervals.
Provide the necessary support on creating/updating the study specific documents as needed.
Update all the dashboards for metrics generation
Manage scheduling and time constraints across multiple projects at a time, set goals based on priorities from management, and adapt to timeline or priority changes by reorganizing daily workload.
Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for opinions of others.
Engage in knowledge share activities.
What You Need to Succeed (minimum qualifications):
BS or equivalent in IT, statistics or scientific field related to animal/human health, or relevant work experience in the animal health industry
10 > 10 years’ Experience working in a global network or supporting a global network, specifically in animal/human health R&D
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/or clinical trial data experience
Knowledge of electronic data capture systems
Experience interacting with regulatory authorities and regulatory submissions.
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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