Senior clinical programmer (Rave)

Accountabilities:: Lead and execute Medidata Rave programming activities, including study builds, custom functions development, database configuration, migration activities, and related clinical programming deliverables. Develop, validate, and maintain software solutions using established development procedures to meet project specifications, quality requirements, and delivery timelines. Prepare and maintain technical documentation covering specifications, coding, validation, annotated Case Report Forms (CRFs), database creation, edit checks, coding setup, data imports and exports, listings, and custom reports. Provide application administration and technical support for clinical systems and tools, including Medidata Rave, Oracle Clinical/Remote Data Capture (OC/RDC), Oracle Inform, SAS, and associated reporting and migration utilities. Monitor application performance, workflow alerts, system errors, and programming defects, investigating issues and implementing appropriate resolutions. Coordinate system integrations, application updates, software upgrades, and user acceptance testing to maintain system reliability and operational effectiveness. Lead programming activities across multiple clinical studies, overseeing study deliverables, timelines, resource requirements, and project-level progress. Depending on program scope and resourcing, provide oversight for approximately five to twenty concurrent studies. Review programming deliverables and multi-study core outputs for technical accuracy, consistency, and quality. Support sponsor audits and assist with ongoing audit activities. Collaborate with clients, lead programmers, project managers, and other stakeholders to clarify requirements, finalize specifications, communicate risks, and resolve project challenges. Monitor project scope, budgets, metrics, and progress, identify potential scope changes, support the preparation and execution of change orders, and escalate issues that could affect timelines or costs. Participate in project reviews, departmental meetings, bid defense activities, and Quick Start Camps (QSCs) as the lead clinical programmer for assigned studies. Provide technical leadership, coaching, training, and mentorship to team members, supporting professional development and the effective distribution of project responsibilities. Manage project resources and workload priorities, communicating staffing and delivery needs proactively to management. Support vendor management activities, including monitoring service-level agreements (SLAs), reviewing performance metrics, coordinating escalations, and overseeing upgrades or implementations of remotely hosted applications. Contribute to the development and maintenance of standard operating procedures, work instructions, and departmental processes while keeping technical knowledge current through continued learning and professional development. Where required, supervise clinical programming teams, assign and review work, support performance evaluations, establish development goals, and help resolve program-level priorities and conflicts. Requirements: Five to seven or more years of overall professional experience in clinical programming, with at least two years of hands-on experience developing moderate-to-complex custom functions. Demonstrated experience in Medidata Rave programming and multiple aspects of clinical study build and configuration. Experience with clinical programming migrations, Publish Check, PPC, TSDV, and study build programming. Mandatory SDBE Rave certification. Strong understanding of clinical data management systems, clinical trial workflows, programming validation, and the quality requirements associated with clinical research. Experience supporting application administration, system integrations, software updates, user acceptance testing, and troubleshooting clinical programming issues. Ability to develop and maintain detailed technical documentation, including specifications, validation records, database configurations, edit checks, and reporting deliverables. Proven ability to coordinate multiple studies or complex programming projects, manage competing priorities, and deliver high-quality work within established timelines and budgets. Strong analytical, problem-solving, and organizational skills, with the ability to assess project risks, identify scope changes, and communicate issues proactively. Experience collaborating with clients, project managers, technical teams, and subject matter experts to clarify requirements and maintain alignment on deliverables. Demonstrated leadership and mentoring capabilities, with experience guiding colleagues, providing technical reviews, and supporting team development. Direct people-management experience is valuable for positions involving team supervision. Strong written and verbal communication skills, attention to detail, and the ability to work effectively in a distributed, cross-functional environment. Familiarity with Veeva CDMS is preferred. A commitment to continuous learning and staying current with clinical programming tools, industry practices, and applicable departmental procedures. Benefits: Remote working arrangement within India. Full-time employment opportunity. Opportunities to work on clinical programming projects supporting drug development and clinical research. Professional development and career progression opportunities. Access to technical training, therapeutic-area learning, and knowledge-sharing initiatives. Supportive management, peer recognition, and a total rewards program. Collaboration with global teams and experienced professionals across clinical and technical disciplines. An inclusive working environment that encourages diverse perspectives, teamwork, and continuous improvement. Specific salary details, healthcare coverage, paid leave entitlements, and other benefit amounts are not specified in the available job description.