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Clinical Study Build Programmer
Eli Lilly and Company. Program and test clinical trial data collection databases, including mapping, testing, and normalization into a clinical data warehouse .
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Program and test clinical trial data collection databases, including mapping, testing, and normalization into a clinical data warehouse
- Configure clinical data collection systems such as eCOA/EDC platforms
- Build study forms, logic, edit checks, workflows, integrations, and data repository mappings
- Gather and influence eCOA design specifications and support implementation
- Understand study translation needs and enable localization
- Deliver accurate data collection systems and data warehouse mappings aligned with study objectives
- Provide insights into study design and data delivery, including the Data Management Plan, Project Plan, database, and observed datasets
- Support submission, inspection, and regulatory response activities
- Lead complex cross-Business Unit/Therapeutic Area projects or programs
- Develop and test innovative solutions
- Improve development speed, accuracy, consistency, and study build cycle time
- Enable metrics reporting for study development timelines and database changes
- Partner with Data and Analytics colleagues to deliver study databases before first patient visit
- Influence data standard decisions and strategies
- Apply regulatory and privacy requirements to study database building
- Integrate multifunctional, external, and technical information for data-driven decisions
- Reduce postproduction changes through change-control processes
- Anticipate and resolve technical, operational, and business problems affecting Data and Analytics
- Manage delivery risks and define database solutions and timelines for the portfolio
Requirements
What you’ll need- Master’s degree in a scientific field such as Informatics/Analytics, Life Sciences, Statistics, Information Technology, Epidemiology, or Computer Sciences, plus 3 years of related experience
- Alternatively, bachelor’s degree plus 5 or more years of experience in clinical data management or closely intersecting areas
- Experience with designing and handling eCOA data
- Ability to articulate data flow from patient to analysis and apply this knowledge to data solutions
- Experience deciding technology platforms for data acquisition and aggregation
- Clinical/drug development knowledge and ability to liaise with study team members
- Strong therapeutic/scientific knowledge in the research field
- Familiarity with clinical data tools and technologies
- Understanding and experience using data standards
- Ability to balance multiple activities, prioritize, and manage ambiguity
- Domestic and international travel may be required
- Knowledge of applicable internal, external, and regulatory requirements/expectations, including MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, and privacy requirements
Benefits
Comp & perks- Company bonus depending partly on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical, dental, vision, and prescription drug benefits
- Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
- Employee resource groups offering support networks