Project Lead Data Manager
Elanco
August 13, 2026
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
Project Lead Data Manager
Your Responsibilities:
- Lead the end-to-end technical lifecycle of clinical data management for assigned projects, from CRF design and database build to final database lock and archival.
- Author and maintain Study Data Management Plans (DMPs) and Data Validation Specifications (DVS).
- Drive data integrity through robust data cleaning strategies; validate and execute Data Management (DM) activities against regulatory requirements (including GxP) and internal SOPs.
- Manage technical deliverables from CROs and third-party vendors, ensuring quality standards and project timelines.
- Educate and advocate for DM policies and procedures with internal and external stakeholders.
- Coach and mentor junior Data Management colleagues.
What You Need to Succeed (Minimum Qualifications):
- Bachelor’s degree (BS) or equivalent in a scientific field, or relevant work experience in animal health or a related industry.
- Minimum 5 years in Clinical Data Management with proven experience supporting global R&D initiatives.
- Demonstrated leadership and adaptability in interdisciplinary, fast-paced environments.
Technical Skills:
- Advanced proficiency in EDC platforms and understanding of the clinical database development lifecycle (design, UAT, lock).
- Proven ability to author/manage DM documents (DMPs, DVS).
- Expertise in data cleaning, query management, and oversight of data integrity in a GxP environment.
Preferred Qualifications:
- Experience with clinical trial data for regulatory authority submissions (e.g., FDA, EMA).
- Advanced knowledge of modern EDC systems and data visualization tools.
- Experience in clinical study monitoring or formal project management.
Benefits and Perks (highlights):
- Multiple relocation packages; two weeklong shutdowns; 8-week parental leave; annual bonus offering; flexible work arrangements; up to 6% 401K matching.
Additional Information / Location:
- Travel: 10% or less annually. Hybrid role based in Indianapolis, IN (Global Elanco Headquarters).
Your Responsibilities:
- Lead the end-to-end technical lifecycle of clinical data management for assigned projects, from CRF design and database build to final database lock and archival.
- Author and maintain Study Data Management Plans (DMPs) and Data Validation Specifications (DVS).
- Drive data integrity through robust data cleaning strategies; validate and execute Data Management (DM) activities against regulatory requirements (including GxP) and internal SOPs.
- Manage technical deliverables from CROs and third-party vendors, ensuring quality standards and project timelines.
- Educate and advocate for DM policies and procedures with internal and external stakeholders.
- Coach and mentor junior Data Management colleagues.
What You Need to Succeed (Minimum Qualifications):
- Bachelor’s degree (BS) or equivalent in a scientific field, or relevant work experience in animal health or a related industry.
- Minimum 5 years in Clinical Data Management with proven experience supporting global R&D initiatives.
- Demonstrated leadership and adaptability in interdisciplinary, fast-paced environments.
Technical Skills:
- Advanced proficiency in EDC platforms and understanding of the clinical database development lifecycle (design, UAT, lock).
- Proven ability to author/manage DM documents (DMPs, DVS).
- Expertise in data cleaning, query management, and oversight of data integrity in a GxP environment.
Preferred Qualifications:
- Experience with clinical trial data for regulatory authority submissions (e.g., FDA, EMA).
- Advanced knowledge of modern EDC systems and data visualization tools.
- Experience in clinical study monitoring or formal project management.
Benefits and Perks (highlights):
- Multiple relocation packages; two weeklong shutdowns; 8-week parental leave; annual bonus offering; flexible work arrangements; up to 6% 401K matching.
Additional Information / Location:
- Travel: 10% or less annually. Hybrid role based in Indianapolis, IN (Global Elanco Headquarters).