Project Lead Data Manager

About Elanco Elanco is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets. Job Overview As a Project Lead Data Manager, you will serve as a technical authority and strategic leader in achieving our global clinical data management objectives. Your role focuses on advancing the end-to-end technical lifecycle of clinical studies, ensuring data capture, management, and archival processes are executed with precision across both electronic and paper-based systems. You will collaborate closely with cross‑functional partners in Clinical Development, Biostatistics, and Regulatory Affairs to guide data management strategies that result in the on‑target delivery of submission‑ready databases, maintaining rigorous quality standards and full compliance with regulatory requirements and Good Clinical Practice (GxP) guidelines. Key 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 DM policies and procedures with internal and external stakeholders. Coach and mentor junior DM colleagues, fostering a positive and collaborative team environment. Required Qualifications Bachelor’s degree (BS) or equivalent in a scientific field, or relevant work experience in animal health or a related industry. Minimum of 5 years in Clinical Data Management, with proven experience supporting global Research & Development initiatives. Demonstrated leadership skills, ability to work effectively within interdisciplinary teams, high adaptability, flexibility, and learning agility in a fast‑paced environment. Advanced proficiency in Electronic Data Capture (EDC) platforms and deep understanding of the clinical database development lifecycle, including design, User Acceptance Testing (UAT), and lock procedures. Proven ability to author and manage essential Data Management documents, including DMPs and DVS. Expertise in data cleaning methodologies, query management, and oversight of data integrity within a Good Clinical Practice (GxP) environment. 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. Benefits Comprehensive benefits package focusing on financial, physical, and mental well‑being. Multiple relocation packages. Two weeklong shutdowns (mid‑summer and year‑end) in the US (in addition to PTO). 8‑week parental leave. Annual bonus. Flexible work arrangements. Up to 6% 401(k) matching. Location & Travel Hybrid role based at Global Elanco Headquarters in Indianapolis, IN. Travel: 10% or less on an annual basis. Equal Employment Opportunity Statement 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. #J-18808-Ljbffr