Principal Clinical Programmer

• Design, write, validate, and maintain clinical programming software using Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS, and supporting tools
• Generate and maintain documentation for specifications, programming, validation, annotated CRFs, databases, coding, edit checks, imports, exports, listings, and custom reports
• Coordinate and lead development activities for clinical programming projects
• Participate in project meetings, discussions, problem solving, and deliverable planning
• Escalate issues affecting project dates, scope, or budget
• Provide technology support to clinical programmers, Project Analysts, Data Managers, and other staff
• Administer and provide technical support for core business applications and supplemental packages
• Perform senior reviews of study-level, program-level, and multi-study deliverables
• Attend sponsor audits and assist with in-progress audits
• Review study budgets, monitor scope against actual work, and manage change orders
• Monitor workflow alerts, system errors, and performance issues
• Perform system integration, application updates, and user acceptance testing
• Provide leadership, training, guidance, and support to department members
• Collaborate with clients, peers, lead programmers, project teams, and requestors to finalize specifications
• Lead assigned studies as the Clinical Programmer role at Quick Start Camps
• Lead clinical programming activities on three to ten concurrent studies
• Manage project resources and proactively communicate delivery and resourcing needs
• Maintain current knowledge through literature, self-training, courses, and professional meetings

• Experience and deep expertise in clinical programming and clinical data management
• Proficiency with Medidata Rave, Oracle OC/RDC, Oracle Inform, SAS, and related supporting tools
• Ability to design, write, validate, and maintain software according to specifications and standard development procedures
• Experience developing specifications, programs, and validation documentation for annotated CRFs, database creation, coding configuration, edit checks, import/export processing, listings, and custom reports
• Ability to coordinate and lead clinical programming project activities
• Analytical problem-solving skills
• Ability to manage multiple concurrent task assignments and studies
• Ability to provide technology support and second-tier help desk support
• Experience with application administration, system integration, application updates, and user acceptance testing
• Ability to conduct senior review of study-level, program-level, and multi-study core deliverables
• Ability to review study budgets, monitor scope of work, and manage change orders
• Ability to provide leadership, training, guidance, and support to department members
• Broad knowledge of clinical programming and clinical data management
• Equivalent experience, skills, and/or education may be considered

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Reasonable accommodations, when appropriate, for employees or applicants with disabilities