Job Title: Senior Clinical Programmer
Location: Remote (India)
Job ID: 25105493
Employment Type: Full-Time
Industry: Clinical Data Management | Clinical Programming | Biostatistics | CRO
Syneos Health is seeking a highly experienced Senior Clinical Programmer to join its Clinical Development team in a fully remote capacity (India). This role is ideal for professionals with advanced expertise in Medidata Rave study build, clinical database programming, and regulatory-compliant data systems supporting global clinical trials.
As a leading biopharmaceutical solutions organization operating in over 110 countries, Syneos Health accelerates drug development through integrated clinical, medical affairs, and commercialization solutions.
The Senior Clinical Programmer is responsible for leading the design, development, validation, and maintenance of clinical trial databases and programming deliverables. This role ensures that clinical data systems meet regulatory standards including FDA, EMA, and ICH-GCP requirements.
This opportunity is well suited for professionals specializing in:
Clinical Programming and Database Development
Medidata Rave Study Build and Configuration
SAS / SQL Programming for Clinical Research
Clinical Data Management (CDM) Systems
Regulatory-Compliant Clinical Data Standards
Utilize core development platforms including:
Medidata Rave
Oracle Inform / Oracle RDC
SAS
Supporting reporting and migration tools
Lead comprehensive study build activities including:
eCRF design and configuration
Edit check programming
Custom function development
Coding setup and validation
Data import/export configuration
Develop and maintain programming specifications, validation documentation, and annotated CRFs.
Generate study listings, reports, and custom outputs for stakeholders.
Lead clinical programming activities across 3–10 concurrent studies depending on scope and complexity.
Collaborate with Data Managers, Biostatisticians, Project Managers, and sponsor teams.
Identify risks related to timelines, scope, or budget and escalate appropriately.
Support sponsor audits and regulatory inspections.
Contribute to budget reviews and manage change orders as required.
Act as subject matter expert for Medidata Rave, Oracle Clinical systems, and SAS environments.
Perform system integrations, application updates, and user acceptance testing (UAT).
Monitor system workflows, alerts, and performance metrics.
Provide second-tier technical support to programming and data management teams.
Conduct senior-level quality reviews of study and multi-study deliverables to ensure accuracy and compliance.
Provide technical leadership and guidance to junior programmers.
Participate actively in project review meetings and departmental discussions.
Maintain updated knowledge of evolving clinical programming technologies and regulatory requirements.
Minimum 5+ years of experience in Clinical Programming, with advanced expertise in Medidata Rave clinical study build and configuration.
Proven experience in:
eCRF design and edit check programming
Custom function programming
Clinical database migration and validation
Hands-on experience managing multiple global clinical trials simultaneously.
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 education and relevant professional experience may be considered.
Certified Clinical Data Manager (CCDM)
SAS Certified Professional
Advanced proficiency in Medidata Rave clinical programming.
Strong programming skills in SAS, SQL, or R.
In-depth understanding of database architecture and validation processes.
Knowledge of global regulatory compliance standards (FDA, EMA, ICH-GCP).
Strong analytical and troubleshooting capabilities.
Excellent written and verbal communication skills.
Ability to work independently in a remote, globally distributed team environment.
Fully remote role within India.
Engagement in global, multi-center clinical development programs.
Opportunity to lead complex programming initiatives across therapeutic areas.
Performance-driven and quality-focused work culture.
This role provides exposure to:
Advanced Clinical Data Architecture
Regulatory Submission Data Standards
Global Study Leadership
Cross-Functional Clinical Development Strategy
Potential progression pathways include:
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 innovative clinical solutions across thousands of research sites and extensive patient populations worldwide.
If you are an experienced Senior Clinical Programmer with Medidata Rave and SAS expertise seeking a remote opportunity in India, this position offers leadership exposure within global clinical development programs.
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Kyiv |Lima Region :
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