Programmer Analyst I (RAVE / Veeva) - should have experience as EDC Designer

Roles & Responsibilities
• Perform independent EDC programming activities using Medidata RAVE across multiple studies with minimal supervision
• Develop and implement solutions for global technical issues related to EDC tools such as Medidata RAVE and Veeva
• Review and understand protocol, requirement documents, specifications, database and report designs
• Create CRF annotations and programming specifications for dataset generation as per CDISC, transfer guidelines, and client standards
• Produce Define XML/PDFs, annotated eCRFs, and Reviewer’s Guides for regulatory submissions
• Develop visual analytics dashboards using tools such as Spotfire or Tableau
• Implement post-production changes including edit checks, listings, protocol deviations, safety gateway, and RTSM (Balance) mappings
• Program and validate datasets, edit checks, and quality checks; communicate data issues to Data Management
• Perform database build reconciliation, project file review, listings, and documentation checks for accuracy and completeness
• Ensure compliance with GCP and regulations related to computerized systems
• Plan and oversee study-level programming activities including timelines, quality, resource estimation, and stakeholder coordination
• Train and mentor team members on EDC tools to enable independent day-to-day operations
• Interact with cross-functional teams and clients to resolve operational and technical issues
• Work independently across multiple sponsors and proactively take on new challenges
• Deliver work within agreed timelines and study budgets as per Fortrea SOPs and work instructions

Qualification
• University or college degree in Life Sciences, Health Sciences, Information Technology, or related field
• Equivalent education and relevant work experience may be considered in lieu of a formal degree

Experience
• 4–7 years of relevant clinical programming experience
• Minimum 2 years of experience in protocol interpretation and EDC study build

Skills
• Strong expertise in Medidata RAVE and EDC programming
• Good understanding of clinical trial processes, data management, biometrics, and clinical systems
• Experience with CDISC standards and submission deliverables
• Strong analytical, problem-solving, and troubleshooting skills
• Ability to work independently with minimal supervision
• Strong communication, time management, and prioritization skills
• Team-oriented mindset with the ability to handle multiple projects and tight deadlines

About the Company
Fortrea is a leading global clinical research organization specializing in clinical development, data management, and pharmacovigilance services. With a strong focus on innovation, regulatory compliance, and advanced clinical technologies, Fortrea partners with biopharmaceutical companies worldwide to deliver high-quality clinical trials and data-driven solutions across the drug development lifecycle.