Senior Global Clinical Data Lead

Elanco Tiergesundheit AG; Indianapolis (IN); Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

Relocation packages

Two weeklong shutdowns (US)

Parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

Up to 6% 401K matching

Job summary

Elanco is seeking a Project Lead Data Manager to act as a technical authority and strategic leader for global clinical data management. You will guide data capture, management, and archival processes across studies, ensuring submission-ready databases meet regulatory standards.

You will collaborate with Clinical Development, Biostatistics, and Regulatory Affairs to deliver datasets compliant with GxP. This role includes mentoring DM staff and driving data quality in a fast-paced hybrid setting

Qualifications

• Requires 5+ years in Clinical Data Management for global R&D initiatives.
• Ability to lead data management strategies in a GxP environment.
• Strong understanding of regulatory requirements and data integrity practices.

Responsibilities

• Lead end-to-end technical lifecycle of clinical data management from CRF design to database lock and archival.
• Author/maintain Study Data Management Plans (DMPs) and Data Validation Specifications (DVS).
• Drive data integrity through data cleaning, queries, and validated DM activities.
• Manage deliverables from CROs and third‑party vendors to Elanco quality standards and timelines.
• Educate and advocate for DM policies and procedures with internal and external stakeholders.
• Coach and mentor junior Data Management colleagues to foster a collaborative team environment.

Skills

Clinical Data Management

Leadership

Regulatory Compliance

Data Quality

Cross-functional Collaboration

Education

Bachelor’s degree in a scientific field

Tools

EDC Platforms

Database Lifecycle

Job description

Elanco is seeking a Project Lead Data Manager to act as a technical authority and strategic leader for global clinical data management. You will guide data capture, management, and archival processes across studies, ensuring submission-ready databases meet regulatory standards.

You will collaborate with Clinical Development, Biostatistics, and Regulatory Affairs to deliver datasets compliant with GxP. This role includes mentoring DM staff and driving data quality in a fast-paced hybrid setting