Roles & Responsibilities
• Maintain eCRF and Edit Check Specification templates in alignment with CDISC standards
• Develop, review, and customize eCRF specifications from database build through database lock
• Create and maintain Edit Check Specifications ensuring protocol and regulatory compliance
• Perform User Acceptance Testing (UAT) and validation of eCRFs and edit checks with complete documentation
• Collaborate with Clinical Database Programmers for accurate technical implementation
• Coordinate with Data Managers and Sponsors to ensure EDC setup meets study expectations
• Design and generate custom EDC reports using tools such as Business Objects and JReview
• Lead and participate in internal and external eCRF specification review meetings
• Ensure quality, consistency, and audit readiness of all database design deliverables
Qualification
• Bachelor’s or Advanced degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, or equivalent
Experience
• Minimum 1 year of hands-on experience in Clinical Data Management
• Experience in EDC database build, eCRF specification development, and edit checks or UAT activities
• Experience with Medidata RAVE or similar EDC systems preferred
Skills
• Strong knowledge of EDC systems and clinical database design
• Understanding of CDISC standards and clinical trial workflows
• Expertise in eCRF design, edit check creation, and UAT execution
• Excellent documentation and attention to detail
• Strong written and verbal communication skills
• Ability to collaborate effectively with cross-functional teams
About the Organisation
Medpace is a globally recognized Clinical Research Organization with over 30 years of experience supporting Phase I–IV clinical trials. Known for its scientific expertise and long-term stability, Medpace provides a growth-oriented environment for clinical research professionals, offering exposure to global studies and advanced clinical data management practices.
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