Senior Clinical Programmer, Rave

• Provide application administration and technical support as a subject matter expert for Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS, migration tools, reporting tools, and custom functions
• Design, write, validate, and maintain software according to specifications and standard development procedures
• Create and maintain documentation for annotated CRFs, database creation, coding setup, edit checks, imports, exports, listings, and custom reports
• Monitor applications for workflow alerts, system errors, performance issues, and programming defects
• Perform system integrations, application updates, and user acceptance testing
• Lead development activities for clinical programming projects and communicate risks affecting dates, scope, or budget
• Participate in project, departmental, and bid defense meetings
• Provide senior review of program-level and multi-study core deliverables
• Attend sponsor audits and assist with in-progress audits
• Review study budgets and manage program metrics, progress, status, scope, and change orders
• Mentor, train, guide, and support department members
• Attend Quick Start Camps as lead Clinical Programmer
• Provide leadership and oversight for five to twenty concurrent studies
• Manage project resources and vendor relationships, including SLAs
• Oversee upgrades and new module implementations for remotely hosted vendors
• Update standard operating procedures and work instructions
• Supervise clinical programming operations and staff development as required

• Experience in Rave Programming
• Custom Functions Programming (Moderate to Complex)
• Minimum 2+ years in Custom Functions (CF)
• Overall 5–7+ years of experience
• Migration exposure
• Publish Check, PPC, and TSDV experience
• Study Build programming experience
• SDBE Rave certification mandatory
• Preferred Veeva CDMS experience
• Broad knowledge of clinical programming and clinical data management
• Ability to design, write, validate, and maintain software
• Ability to generate and maintain required technical and validation documentation
• Ability to perform system integrations, application updates, and user acceptance testing
• Ability to lead clinical programming project activities and oversee concurrent studies
• Ability to manage project resources, metrics, budgets, scope, and change orders
• Ability to provide leadership, mentorship, training, guidance, and supervision
• Ability to manage application vendors and monitor SLAs

• 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