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)
- 9 Employee Resource Groups
- Flexible work arrangements
