Eli Lilly and Company is a global healthcare leader dedicated to discovering and delivering life-changing medicines. Headquartered in Indianapolis, Indiana, Lilly focuses on improving disease management, advancing medical research, and giving back to communities through philanthropy. With a strong commitment to innovation and patient care, Lilly fosters a work environment that values integrity, excellence, and collaboration.
Job Description
Purpose:
The Clinical Data Management Associate/Senior Associate is responsible for medical coding activities at the trial level. This role requires expertise in medical dictionary standards, data collection, validation, and dataset delivery. The candidate will collaborate with Clinical Data Associates, Study Build Programmers, and key stakeholders to ensure high-quality clinical data management for trials.
Primary Responsibilities:
- Execute Lilly’s business requirements for clinical trial data delivery.
- Ensure on-time, high-quality database lock and dataset delivery.
- Manage end-to-end data flow, including niche data sources (pharmacokinetic, immunogenicity, biomarker).
- Contribute to Data Management Plans (DMP), database design, and observed datasets.
- Oversee central coding, data archiving, and decommissioning.
- Ensure compliance with regulatory standards (FDA, ICH, GCP, MHRA, etc.).
- Utilize therapeutic knowledge to enhance data accuracy and consistency.
- Improve processes to reduce cycle time and workload.
Project Management:
- Adapt and implement Lilly’s data standards for study/program requirements.
- Track and report key metrics for study build, execution, and deliverables.
- Facilitate integration of disparate data sources for decision-making.
- Represent Data & Analytics processes in cross-functional initiatives.
Qualifications & Experience:
- Bachelor’s degree in Medical Sciences, Life Sciences, Health Information, Nursing, Pharmacy, or related fields.
- 3-5 years of experience in medical coding within clinical data management.
- Strong understanding of MedDRA, WHO-DD, and other medical dictionaries.
- Knowledge of clinical trial processes, data validation, and regulatory compliance.
- Experience with clinical databases (EDC systems like Medidata Rave, Oracle Clinical, etc.).
Why Join Eli Lilly?
- Work with a global leader in pharmaceutical innovation.
- Engage in cutting-edge clinical research and data management.
- Be part of a collaborative and inclusive workplace.
- Opportunities for career growth and shared learning.
