Project Lead Data Manager – 1030708

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 packagesTwo weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)8-week parental leave9 Employee Resource GroupsAnnual bonus offeringFlexible work arrangementsUp to 6% 401K matchingElanco 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.