Project Lead Data Manager

Location: Indianapolis

# Project Lead Data Manager Back to search results

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** 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…