As a Principal Clinical Programmer, you will provide advanced technical expertise in Electronic Data Capture (EDC) systems and clinical trial programming, with a particular focus on Medidata Rave and complex system integrations. You will lead the design, development, validation, and maintenance of clinical databases and programming solutions that support high-quality clinical research. Working across clinical programming platforms, data structures, and reporting tools, you will ensure that systems meet project specifications, quality standards, and operational requirements. You will collaborate with cross-functional project teams, clients, and technical stakeholders to deliver reliable, efficient, and scalable solutions throughout the clinical development lifecycle. In this senior individual contributor role, you will guide programming activities, troubleshoot complex technical issues, and contribute to successful study implementation. You will also mentor colleagues, share technical knowledge, and help strengthen programming practices in a collaborative, globally connected environment focused on advancing clinical research and patient outcomes.
- 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.
Benefits
- 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.
