Principal Clinical Programmer - EDC Rave

Your tasks

• Clinical Programming and EDC Development: Design, develop, validate, and maintain clinical programming solutions using Medidata Rave and other relevant clinical systems, ensuring compliance with project specifications and established development procedures.
• Application Administration and Technical Support: Serve as a subject matter expert for core clinical applications, including Medidata Rave, Oracle Clinical/Remote Data Capture (OC/RDC), Oracle Inform, SAS, and related reporting, migration, and custom-function tools.
• Clinical Database Configuration: Develop and maintain specifications and programming documentation for annotated Case Report Forms (CRFs), database creation, coding configurations, edit checks, and data import and export processes.
• Reporting and Data Processing: Configure and maintain listings, custom reports, reporting tools, and data processing workflows to support clinical study requirements and ensure accurate, reliable outputs.
• System Integration and Validation: Lead and support system integration activities, application updates, user acceptance testing, and validation processes to ensure system functionality and data integrity.
• Monitoring and Troubleshooting: Proactively monitor applications for workflow alerts, system errors, performance issues, and programming defects, conducting root cause analysis and implementing appropriate resolutions.
• Study Startup and Implementation: Participate in Quick Start Camps (QSCs) as the lead Clinical Programmer for assigned studies, coordinating technical preparation and ensuring programming deliverables are completed effectively.
• Project Coordination and Delivery: Lead programming activities within clinical project teams, participate in technical discussions, clarify requirements, and coordinate deliverables to meet agreed timelines, scope, quality standards, and budget expectations.
• Risk Management and Communication: Identify and communicate technical issues, resource constraints, and potential delivery risks to project managers and relevant stakeholders, escalating concerns promptly when necessary.
• Technical Leadership and Mentoring: Provide guidance, training, mentoring, and technical support to other programming team members, helping strengthen their skills and promote consistent development practices.
• Stakeholder Collaboration: Work closely with clients, lead programmers, project teams, peers, and requestors to define requirements, finalize technical specifications, resolve challenges, and adapt solutions to evolving project needs.
• Continuous Improvement: Apply analytical problem-solving and sound technical judgment to improve programming workflows, application performance, documentation quality, and the reliability of clinical data systems.

Requirements

• Extensive Professional Experience: Approximately 10 or more years of relevant experience in clinical programming, EDC systems, or related technical roles, with a strong preference for candidates with substantial hands-on programming experience rather than primarily clinical data management experience.
• Medidata Rave Expertise: Strong practical knowledge of Medidata Rave and electronic data capture environments, including clinical database configuration, study setup, programming, and system maintenance.
• Clinical Systems Knowledge: Experience administering and supporting clinical technology platforms such as Medidata, Oracle Clinical/OC-RDC, Oracle Inform, SAS, and associated programming or reporting applications.
• Programming and Development Skills: Demonstrated ability to design, develop, test, validate, troubleshoot, and maintain software and programming deliverables in accordance with technical specifications and established procedures.
• Clinical Database and CRF Knowledge: Experience with annotated CRFs, database creation, edit check procedures, coding setup, data imports and exports, listings, and custom reporting.
• System Integration Experience: Strong understanding of application integrations, complex data structures, application updates, user acceptance testing, and validation activities in clinical research environments.
• Technical Documentation: Ability to prepare and maintain clear, comprehensive documentation covering requirements, specifications, development activities, testing, validation, and system configurations.
• Analytical and Troubleshooting Skills: Excellent problem-solving capabilities, with the ability to investigate complex application issues, identify root causes, assess risks, and implement effective technical solutions.
• Project Delivery and Prioritization: Ability to manage multiple programming assignments, balance competing priorities, coordinate deliverables, and communicate progress or potential delays effectively.
• Leadership and Mentoring: Demonstrated ability to provide technical guidance, mentor colleagues, share expertise, and lead programming activities without losing focus on hands-on delivery.
• Communication and Collaboration: Strong written and verbal communication skills, with the ability to work effectively with clients, technical teams, project managers, and cross-functional stakeholders.
• Quality and Attention to Detail: Commitment to programming accuracy, data integrity, validation standards, documentation quality, and reliable delivery within regulated clinical research environments.
• Adaptability: Ability to respond effectively to evolving project requirements, changing technical needs, and complex clinical programming challenges.

What we offer

• Remote work opportunity: The position is listed as remote, with India identified as the eligible work location.
• Career development: Opportunities to strengthen expertise in clinical programming, EDC platforms, system integrations, and clinical technology solutions.
• Technical leadership: Scope to lead complex programming activities, mentor colleagues, and influence development practices.
• Global collaboration: Opportunities to work with international colleagues, clients, and multidisciplinary clinical research teams.
• Continuous learning: Exposure to evolving technologies, clinical research systems, programming tools, and knowledge-sharing initiatives.
• Meaningful contribution: The opportunity to support clinical research programs that help accelerate the development and delivery of new therapies to patients.
• Career progression: Potential to explore broader technical and functional opportunities within a global clinical development environment.
• Inclusive workplace: A collaborative culture that values diverse perspectives, professional growth, and teamwork.

Other

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