Clinical Database Designer

Roles & Responsibilities
• Maintain eCRF and Edit Check Specification standard templates aligned with CDISC standards for data collection and submission
• Develop and maintain study-specific eCRF specifications by reviewing protocols and customizing library eCRFs from database build through database lock, including change requests
• Develop and maintain Edit Check Specifications from build through lock, ensuring data is complete, logical, and aligned with protocol schedules and completion guidelines
• Validate eCRFs and edit checks against specifications, testing all entry scenarios, documenting results, and providing clear feedback to clinical data programmers
• Liaise with and educate Data Managers and Sponsors to ensure eCRFs are understood and the EDC database is configured per sponsor expectations, including attending setup meetings
• Collaborate with Clinical DB Programmers to ensure specifications are clear, feasible, and accurately implemented in the EDC system
• Design and develop customized project-level reports using EDC reporting tools such as Business Objects and JReview
• Lead internal eCRF specification review meetings to align design decisions and technical options with project teams
• Lead external eCRF specification review meetings with sponsors, explain design decisions, and discuss technical design options when changes are requested

Qualification
• Bachelor’s degree or Advanced degree in Life Sciences or Computer Science, or equivalent

Experience
• Minimum 1 year experience building EDC specifications and/or performing UAT for EDC databases

Skills
• eCRF design and specification development
• Edit check specification writing and validation/UAT execution
• Understanding of CDISC standards for data collection and submission
• EDC systems reporting exposure (eg Business Objects, JReview)
• Strong stakeholder communication with sponsors and cross-functional teams
• Excellent written and verbal communication skills
• Meticulous attention to detail and strong documentation discipline

About The Company
Medpace is a full-service global CRO providing Phase I–IV clinical development services to biotechnology, pharmaceutical, and medical device companies, with a mission to accelerate development of safe and effective therapeutics through a disciplined scientific approach. Headquartered in Cincinnati, Ohio, Medpace operates across 40+ countries and is recognized for its capabilities and quality, including repeated Forbes recognition among America’s most successful midsize companies and CRO Leadership Awards.