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.