Senior Principal Clinical Programmer (Medidata RAVE)
Company: Syneos Health
Location: IND-Hyderabad, India
Work Mode: Hybrid
Employment Type: Full-Time
Job Overview
The Senior Principal Clinical Programmer (Medidata RAVE) is a senior leadership-level programming role responsible for end-to-end oversight of clinical database build, EDC configuration, and programming deliverables across multiple studies and programs. The role requires deep expertise in Medidata Rave and strong leadership capabilities to guide teams, manage sponsors, and ensure high-quality, inspection-ready clinical data systems.
Key Responsibilities
Lead clinical programming activities across multiple studies (5–20 concurrent studies) and large programs
Design, build, validate, and maintain Medidata Rave EDC systems and related clinical data applications
Develop specifications, edit checks, database structures, and custom functions in Rave
Perform system integration, migration activities, UAT, and post-go-live updates
Provide technical leadership across clinical programming and data management functions
Act as SME for Medidata Rave, Oracle RDC/Inform, SAS, and clinical data platforms
Monitor system performance, troubleshoot issues, and ensure application stability
Ensure all programming deliverables are audit-ready and compliant with GxP and regulatory standards
Participate in sponsor meetings, bid defenses, and senior management discussions
Manage vendor relationships, SLAs, and external system integrations
Review study budgets, scope changes, and support change order management
Mentor and supervise lead programmers and junior team members
Contribute to SOPs, process improvements, and standardization initiatives
Provide oversight of program-level delivery and resource planning
Required Qualifications
Bachelor’s or Master’s degree in Life Sciences, Computer Science, Statistics, or related field (or equivalent experience)
8+ years of experience in clinical programming
Strong hands-on expertise in Medidata Rave (EDC build, configuration, migrations)
Experience as a Rave SME in large clinical programs
Strong understanding of clinical trial processes and data management systems
Experience with SDTM/clinical data workflows and regulatory compliance (ICH-GCP, GxP)
Preferred Qualifications
Experience with Clinical Metadata Repository (MDR)
Exposure to SAS and clinical reporting tools
Experience in global CRO/pharma environments
Strong stakeholder management and client-facing experience
Experience in process improvement and tool development for clinical programming
Experience Required
8–12+ years in clinical programming with strong Medidata Rave expertise and leadership responsibilities
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