Clinical Data Associate
Eli Lilly and Company
8 days ago
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
The Clinical Data Associate is accountable for end-to-end clinical data sciences delivery for a clinical study, including clinical database build, data acquisition, storage, retrieval, and exchange. Provides clinical data science leadership and ownership for a particular clinical study, set of studies, or programs.
Primary Responsibilities:
- Implement project monitoring and quality oversight of sourcing providers for end-to-end data management (study set-up through database lock).
- Ensure vendor performance for program-level data flow (e.g., PK, immunogenicity, biomarkers).
- Partner to ensure data flow design and data collection meet study protocol requirements.
- Develop and maintain the Data Management Plan (DMP) throughout the study lifecycle.
- Drive data cleaning and post-production changes to the Clinical Database.
- Maintain plans for key deliverables (Data Quality Delivery Plan, Datalock Plan, Project Plan).
- Support inspections and inspection readiness.
- Apply internal/external/regulatory requirements to data deliverables.
- Manage requests for copyrights and translations for study documents.
- Drive and serve as eCOA point of contact (POC).
- Manage scope, timelines (FPV to database lock), readiness, coordination/communication, and data management milestones; perform risk management.
- Act as primary communication point for data management activities.
- Continually pursue process improvements and represent clinical data science processes in cross-functional initiatives.
Minimum Qualifications:
- Master’s degree in a scientific/technical field (or Bachelor’s + 3+ years of related clinical data management experience).
- Legally authorized to work in the United States; no anticipated visa sponsorship.
Preferred Skills/Experience:
- Partner/influence virtual teams; lead creative solutions.
- Programming/tool knowledge: Tableau, PowerBI, Python, SAS, R, Shiny, P-SQL, T-SQL.
- Data flow knowledge (start-up to analysis), therapeutic/scientific knowledge, medical terminology.
- Domestic/international travel; balance multiple activities; teamwork and problem-solving.
Benefits:
- Eligible for company bonus and comprehensive benefit program (401(k), pension, vacation, medical/dental/vision, life insurance, time off/leave, well-being benefits) (full details provided in posting).
Application Instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation form: https://careers.lilly.com/us/en/workplace-accommodation
Primary Responsibilities:
- Implement project monitoring and quality oversight of sourcing providers for end-to-end data management (study set-up through database lock).
- Ensure vendor performance for program-level data flow (e.g., PK, immunogenicity, biomarkers).
- Partner to ensure data flow design and data collection meet study protocol requirements.
- Develop and maintain the Data Management Plan (DMP) throughout the study lifecycle.
- Drive data cleaning and post-production changes to the Clinical Database.
- Maintain plans for key deliverables (Data Quality Delivery Plan, Datalock Plan, Project Plan).
- Support inspections and inspection readiness.
- Apply internal/external/regulatory requirements to data deliverables.
- Manage requests for copyrights and translations for study documents.
- Drive and serve as eCOA point of contact (POC).
- Manage scope, timelines (FPV to database lock), readiness, coordination/communication, and data management milestones; perform risk management.
- Act as primary communication point for data management activities.
- Continually pursue process improvements and represent clinical data science processes in cross-functional initiatives.
Minimum Qualifications:
- Master’s degree in a scientific/technical field (or Bachelor’s + 3+ years of related clinical data management experience).
- Legally authorized to work in the United States; no anticipated visa sponsorship.
Preferred Skills/Experience:
- Partner/influence virtual teams; lead creative solutions.
- Programming/tool knowledge: Tableau, PowerBI, Python, SAS, R, Shiny, P-SQL, T-SQL.
- Data flow knowledge (start-up to analysis), therapeutic/scientific knowledge, medical terminology.
- Domestic/international travel; balance multiple activities; teamwork and problem-solving.
Benefits:
- Eligible for company bonus and comprehensive benefit program (401(k), pension, vacation, medical/dental/vision, life insurance, time off/leave, well-being benefits) (full details provided in posting).
Application Instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation form: https://careers.lilly.com/us/en/workplace-accommodation