Job Title: Senior Clinical Programmer
Location: Hyderabad, India (Hybrid Work Model)
Job ID: 25105493
Employment Type: Full-Time
Industry: Clinical Data Management | Clinical Programming | CRO | Biostatistics
Syneos Health is hiring an experienced Senior Clinical Programmer to join its Clinical Development team in Hyderabad under a hybrid work model. This role is designed for professionals with strong expertise in Medidata Rave study build, clinical database programming, and regulatory-compliant data systems within global clinical trials.
As a leading biopharmaceutical solutions organization operating in over 110 countries, Syneos Health partners with pharmaceutical and biotechnology companies to accelerate clinical development and regulatory approvals.
The Senior Clinical Programmer is responsible for designing, programming, validating, and maintaining clinical trial databases and associated programming deliverables. This role supports clinical data management, statistical analysis, and regulatory submission readiness in compliance with FDA, EMA, and ICH-GCP standards.
This opportunity is ideal for professionals looking to advance in:
Clinical Programming and Study Build
Medidata Rave and Oracle Clinical Systems
SAS / SQL Programming for Clinical Trials
Clinical Data Management (CDM)
Regulatory-Compliant Database Design
Utilize primary development tools including:
Medidata Rave
Oracle Inform / Oracle RDC
SAS
Supporting reporting and migration tools
Lead end-to-end study build activities including:
eCRF design and configuration
Edit check programming
Custom function development
Coding setup and dictionary configuration
Data import and export setup
Develop and maintain programming specifications, validation documentation, and annotated CRFs.
Generate listings, custom reports, and study-level deliverables.
Lead clinical programming activities across 3 to 10 concurrent studies depending on complexity and scope.
Coordinate with Data Managers, Biostatisticians, Project Managers, and sponsors.
Identify risks to scope, timelines, and budget, escalating issues proactively.
Review study budgets and manage change orders when scope modifications occur.
Participate in sponsor audits and support regulatory inspections.
Serve as subject matter expert for clinical systems including Medidata Rave, Oracle Inform, Oracle RDC, and SAS.
Perform system integration activities, application updates, and user acceptance testing (UAT).
Monitor workflows, system alerts, and performance issues.
Provide second-tier technical support to clinical programming and data management teams.
Conduct senior-level quality review of study and program-level deliverables to ensure data integrity and compliance.
Provide technical guidance, mentorship, and training to junior programmers.
Actively contribute to project and departmental review meetings.
Maintain current knowledge of clinical programming technologies, regulatory standards, and industry best practices.
Minimum 5+ years of experience in Clinical Programming, with advanced hands-on expertise in Medidata Rave study build and configuration.
Demonstrated experience in:
eCRF design and database configuration
Edit check programming
Custom function programming
Clinical database migration and validation
Experience managing multiple concurrent global clinical trials.
Prior exposure to sponsor audits and regulatory inspections is preferred.
Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related discipline.
Equivalent combination of education and relevant industry experience may be considered.
Certified Clinical Data Manager (CCDM)
SAS Certified Professional or equivalent certification
Advanced proficiency in Medidata Rave clinical programming.
Strong programming skills in SAS, SQL, or R.
In-depth understanding of clinical database design, validation, and integration.
Knowledge of regulatory requirements including FDA, EMA, and ICH-GCP.
Strong analytical, problem-solving, and troubleshooting skills.
Ability to manage multiple priorities in a fast-paced clinical development environment.
Excellent written and verbal communication skills.
Hybrid work model based in Hyderabad, India.
Exposure to global, multi-center clinical trials.
Leadership role within cross-functional clinical development teams.
Opportunity to contribute to regulatory submission-ready data systems.
This position provides strategic exposure to:
Advanced Clinical Data Architecture
Regulatory Submission Data Standards
Cross-Functional Clinical Development Leadership
Multi-Study Programming Oversight
Potential career progression includes:
Lead Clinical Programmer
Clinical Programming Manager
Associate Director, Clinical Data Systems
Director, Clinical Data Management
Syneos Health has supported 94% of novel FDA-approved drugs and 95% of EMA-authorized products in recent years. With more than 29,000 employees globally, the organization delivers clinical research solutions across thousands of sites and hundreds of thousands of patients worldwide.
If you are a skilled Senior Clinical Programmer with Medidata Rave and SAS expertise, this hybrid opportunity in Hyderabad offers a platform to lead global clinical database initiatives within a high-performing CRO environment.
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