Principal Clinical Programmer

Job Title: Principal Clinical Programmer

Location: India (Remote)

About the Role

We are seeking an experienced Principal Clinical Data Programmer to join our Clinical EDC Programming team at Caidya. This role combines advanced technical expertise with clinical data strategy, collaborative problem-solving, and leadership in the evolution of clinical database design and integrated data management.

As the clinical research industry increasingly embraces quality by design, risk-based approaches, analytics, and AI-enabled technologies, the role of Clinical Programming is expanding beyond traditional database development. Our Principal Clinical Programmers are expected to help shape how studies are designed and configured, applying their technical knowledge alongside an understanding of protocol objectives, critical-to-quality factors, and downstream data review needs.

The ideal candidate will bring extensive hands-on experience with Medidata Rave EDC, including advanced Custom Function programming, complex study builds, and clinical system integrations. Experience with Veeva Vault CDMS is preferred, while exposure to Medidata Designer, Clinical Data Studio (CDS), analytics, and AI-assisted workflows is an advantage.

Working closely with Data Management, Clinical Operations, sponsors, and other cross-functional teams, this individual will provide technical leadership, challenge traditional approaches where appropriate, influence database design decisions, and help advance Caidya's transition toward more integrated, efficient, and data-driven clinical trial processes.

Key Responsibilities

• Provide technical leadership in the design, configuration, validation, and maintenance of complex clinical study databases in accordance with study protocols, SOPs, GCP, and regulatory requirements.
• Partner with Data Management and other study functions to translate protocol objectives, critical-to-quality factors, and data review requirements into effective clinical database design strategies.
• Lead collaborative database design discussions, evaluating alternative approaches and recommending solutions that balance data quality, operational efficiency, study complexity, and downstream analytics needs.
• Develop and maintain advanced edit checks, derivations, custom programming, and complex database configurations, providing expert guidance across EDC platforms.
• Provide technical oversight for complex study builds, database migrations, post-production changes, and integrations across clinical systems.
• Support the adoption and optimization of Medidata Designer, including AI-assisted study configuration and evolving approaches to protocol-driven database development.
• Contribute to the implementation and optimization of Clinical Data Studio (CDS), supporting integrated data review, analytics, external data ingestion, and risk-based data management capabilities.
• Collaborate with Data Management, Clinical Operations, Biostatistics, Medical Monitoring, sponsors, and external partners to develop solutions that support cross-functional data review and high-quality clinical data delivery.
• Apply quality-by-design and risk-based principles to database configuration, validation strategies, and clinical data workflows.
• Provide technical expertise in evaluating complex programming challenges, system limitations, integration requirements, and opportunities for process improvement.
• Contribute to programming standards, global libraries, technical guidelines, and governance processes that support consistency and efficient study delivery.
• Mentor Clinical Programmers, promote critical thinking and collaborative problem-solving, and support the team's transition toward more consultative and strategically engaged roles.
• Identify and champion opportunities to improve clinical programming through automation, analytics, AI-assisted workflows, and emerging technologies.
• Collaborate with programming leadership and study teams to assess technical requirements, manage risks, and support delivery of study milestones.
• Actively contribute to the evolution of clinical programming practices, helping ensure that technical solutions remain aligned with changing industry expectations and clinical data management strategies.

Qualifications

• Bachelor's degree or advanced degree in computer science, life sciences, health informatics, mathematics, or a related field, or equivalent combination of education and experience.
• Minimum 10 years of experience in clinical database design, clinical programming, and EDC systems within the pharmaceutical, biotechnology, or CRO industry.
• Extensive hands-on experience with Medidata Rave EDC required, including advanced edit check programming, derivations, Custom Functions, and complex study build activities.
• Strong C# programming experience, particularly for Medidata Rave Custom Function development.
• Experience with complex database migrations, post-production changes, and clinical system integrations.
• Experience with Veeva Vault CDMS preferred; Medrio and Oracle InForm experience are also beneficial.
• Experience with Medidata Designer and/or Clinical Data Studio (CDS) is a plus.
• Strong understanding of clinical trial design, protocol requirements, GCP, regulatory expectations, and clinical data standards.
• Understanding of quality-by-design principles, risk-based data management, critical-to-quality factors, and integrated clinical data review approaches.
• Experience with centralized data review, analytics, automation, or AI-enabled clinical data workflows is beneficial.
• Demonstrated ability to evaluate complex study requirements, challenge assumptions constructively, and recommend effective technical and operational solutions.
• Strong analytical, critical-thinking, problem-solving, and decision-making capabilities.
• Excellent communication, collaboration, and stakeholder engagement skills, including the ability to influence cross-functional discussions and explain complex technical concepts.
• Experience providing technical leadership, mentoring colleagues, and contributing to process or technology improvements.
• Curiosity, adaptability, and a forward-thinking approach to emerging technologies and evolving clinical data management practices.
• Ability to work independently, manage complex priorities, and collaborate effectively within a global, remote team.

Why Join Us?

• Be part of a growing, innovation-focused CRO where your expertise and ideas can directly influence how clinical data solutions are delivered.
• Help shape the evolution of clinical data management through quality-by-design principles, integrated data review, analytics, and AI-enabled technologies.
• Work with modern clinical platforms, including Medidata Rave, Designer, and Clinical Data Studio.
• Join collaborative global teams that value knowledge sharing, technical excellence, fresh perspectives, and continuous improvement.
• Enjoy the flexibility of a remote work environment that supports work-life balance.
• Gain exposure to diverse global studies, clients, and emerging clinical data strategies across multiple therapeutic areas.
• Contribute beyond study delivery through technical leadership, process optimization, innovation initiatives, and standards development.
• Experience the agility and visibility of a mid-sized CRO where individual contributions can make a meaningful impact.

If you are an experienced clinical programming professional who combines technical expertise with strategic thinking, enjoys challenging traditional approaches, and wants to help shape the future of clinical data management, we encourage you to apply.