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.