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:
Project Lead Data Manager
As a Project Lead Data Manager, you will serve as a technical authority and strategic leader in achieving our global clinical data management objectives. In this role, you will be responsible for advancing the end-to-end technical lifecycle of clinical studies, ensuring that data capture, management, and archival processes are executed with precision across both electronic and paper-based systems. By collaborating closely with cross-functional partners in Clinical Development, Biostatistics, and Regulatory Affairs, you will guide data management strategies that result in the on-target delivery of submission-ready databases, ensuring all deliverables meet rigorous quality standards and are fully compliant with regulatory requirements and Good Clinical Practice (GxP) guidelines.
Your Responsibilities:
Lead the end-to-end technical lifecycle of clinical data management for assigned projects, from initial Case Report Form (CRF) design and database build to final database lock and archival.
Author and maintain comprehensive Study Data Management Plans (DMPs) and Data Validation Specifications (DVS) to ensure alignment with study protocols and regulatory requirements.
Drive data integrity through robust data cleaning strategies and ensure all technical Data Management (DM) activities are validated and executed against regulatory requirements (including Good Clinical Practice - GxP) and internal SOPs.
Manage technical deliverables from Contract Research Organizations (CROs) and third-party vendors, ensuring adherence to Elanco’s quality standards and project timelines.
Educate and advocate for Data Management (DM) policies and procedures with both internal and external stakeholders.
Coach and mentor junior Data Management colleagues, fostering a positive and collaborative team environment.
What You Need to Succeed (minimum qualifications):
Education: Bachelor’s degree (BS) or equivalent in a scientific field, or relevant work experience in animal health or a related industry.
Experience: A minimum of 5 years in Clinical Data Management, with proven experience supporting global Research & Development (R&D) initiatives.
Leadership & Adaptability: Demonstrated leadership skills with the ability to work effectively within interdisciplinary teams, showing high levels of adaptability, flexibility, and learning agility in a fast-paced environment.
Technical Skills:
EDC & Database Lifecycle: Advanced proficiency in Electronic Data Capture (EDC) platforms and a thorough understanding of the clinical database development lifecycle, including design, User Acceptance Testing (UAT), and lock procedures.
Data Management Documentation: Proven ability to author and manage essential Data Management (DM) documents, including Data Management Plans (DMPs) and Data Validation Specifications (DVS).
Data Quality: Expertise in data cleaning methodologies, query management, and the oversight of data integrity within a Good Clinical Practice (GxP) environment.
What will give you a competitive edge (preferred qualifications):
Direct experience with clinical trial data for regulatory authority submissions (e.g., FDA, EMA).
Advanced knowledge of modern Electronic Data Capture (EDC) systems and data visualization tools.
Previous experience in clinical study monitoring or formal project management.
Additional Information:
Travel: 10% or less on an annual basis.
Location: This is a hybrid role based at our Global Elanco Headquarters in Indianapolis, IN.
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 Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
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 may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.
Skills Required
- Bachelor's degree in a scientific field or equivalent experience
- Minimum 5 years clinical data management experience supporting global R&D
- Advanced proficiency with Electronic Data Capture (EDC) platforms and clinical database lifecycle (design, UAT, lock)
- Proven ability to author and maintain Data Management Plans (DMPs) and Data Validation Specifications (DVS)
- Expertise in data cleaning methodologies, query management, and ensuring data integrity in a GxP environment
- Experience managing technical deliverables from CROs and third-party vendors
- Demonstrated leadership, coaching, and cross-functional collaboration skills
- Direct experience with clinical trial data for regulatory submissions (FDA, EMA)
- Advanced knowledge of modern EDC systems and data visualization tools
- Experience in clinical study monitoring or formal project management
Elanco Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Elanco and has not been reviewed or approved by Elanco.
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Leave & Time Off Breadth — Time off options are broad, including PTO, flexible leave, and the ability to purchase additional vacation. These provisions are highlighted as supportive of work-life balance.
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Healthcare Strength — Health coverage includes medical, dental, and vision alongside company-paid life, disability, and wellness support. Pet insurance and assistance programs reinforce a comprehensive wellbeing offering.
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Retirement Support — Retirement offerings include a U.S. 401(k) and, for some employees, access to a defined benefit pension. These programs add meaningful long-term value to total rewards.
Elanco Insights
What We Do
At Elanco, we work to improve the health of animals through innovative products and services for pets and farm animals around the world. As a global animal health company, we provide solutions that empower our customers to advance a vision of Food and Companionship Enriching Life. Since 1954, Elanco has committed to empowering veterinarians, farmers, and all those who care for animals with the tools they need to help animals live healthy lives. Healthier animals are the key to making our lives better - This is the fundamental belief uniting all global Elanco employees. That’s why we are committed to the idea that our business can be a unique force for good for all in society. Through our Elanco Healthy Purpose™ framework of Environmental, Social and Governance (ESG) commitments, we focus on delivering sustainable solutions to advance the well-being of animals, people and the planet. This program also enables our employees around the world to take paid time off to make an impact as a volunteer, offering their time or talent to give back to our customers, causes and communities. #ElancoHealthyPurpose #WeAreElanco
