Senior Medidata Developer - Clinical Data Management

Description : Position Overview :

We are seeking a Senior Medidata Consultant / Developer with extensive experience in Medidata EDC (Rave) and Medidata Coder platforms to support, enhance, and optimize clinical trial data management systems.

The ideal candidate will possess a strong understanding of clinical data workflows , along with solid technical troubleshooting, configuration , and integration expertise.

This role involves close collaboration with global clinical operations, data management, and IT teams to ensure seamless system performance and data quality throughout the clinical lifecycle.

Key Responsibilities :

• Serve as a subject matter expert (SME) for Medidata EDC and Medidata Coder , overseeing configuration, deployment, and maintenance across multiple clinical studies.
• Lead the design, development, and implementation of enhancements, custom configurations, and integrations within Medidata platforms.
• Conduct advanced troubleshooting and root cause analysis for complex application and data-related issues, ensuring minimal disruption to business operations.
• Support system integrations with downstream and upstream applications (e.g., CTMS, RIM, Safety, and BI tools).
• Collaborate with clinical data management teams to optimize data capture, coding accuracy, and study setup within EDC.
• Partner with Medidata vendor teams and internal IT to manage releases, patches, and validation activities.
• Develop and maintain technical documentation , SOPs, and configuration guides in line with regulatory and compliance requirements.
• Provide guidance and mentorship to junior team members and participate in cross-functional knowledge sharing.
• Ensure all solutions comply with GxP, 21 CFR Part 11 , and corporate validation policies.
• Actively contribute to continuous improvement initiatives, automation opportunities, and process efficiency enhancements.

Required Skills & Qualifications

(ref : hirist.tech)