Global Clinical Data Lead & Project Manager (Hybrid)

Elanco in; Indianapolis (IN); Hybrid; USD 113,000 - 138,000; Full time

Benefits offered by this job

Relocation packages

Shutdowns

Parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

401K matching

Job summary

Elanco is seeking a Project Lead Data Manager to serve as a technical authority and strategic leader in achieving global clinical data management objectives.

You will drive the end-to-end lifecycle of data capture, management, and archival across electronic and paper systems, collaborating with Clinical Development, Biostatistics, and Regulatory Affairs to deliver submission-ready databases in compliance with GxP.

Qualifications

• Bachelor's degree or equivalent in a scientific field.
• Minimum of 5 years in Clinical Data Management with global R&D experience.
• Proven leadership within interdisciplinary teams and fast-paced environments.

Responsibilities

• Lead the end-to-end technical lifecycle of clinical data management for assigned projects, from initial 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.

Skills

EDC platforms

DM lifecycle

Leadership

Education

Bachelor's degree in a scientific field

Job description

Elanco is seeking a Project Lead Data Manager to serve as a technical authority and strategic leader in achieving global clinical data management objectives.

You will drive the end-to-end lifecycle of data capture, management, and archival across electronic and paper systems, collaborating with Clinical Development, Biostatistics, and Regulatory Affairs to deliver submission-ready databases in compliance with GxP.