Job Title: Senior Clinical Programmer
Location: Pune, India (Hybrid Work Model)
Job ID: 25105493
Employment Type: Full-Time
Industry: Clinical Data Management | Clinical Programming | CRO | Biostatistics
Syneos Health is seeking an experienced Senior Clinical Programmer to join its Clinical Development team in Pune under a hybrid work model. This role is ideal for professionals with advanced expertise in Medidata Rave clinical programming, database design, and regulatory-compliant clinical data systems within a global CRO environment.
As a leading biopharmaceutical solutions organization operating in over 110 countries, Syneos Health supports end-to-end clinical development programs that accelerate drug approvals and bring therapies to patients worldwide.
The Senior Clinical Programmer is responsible for designing, developing, validating, and maintaining clinical trial databases and programming deliverables. The position plays a critical role in supporting clinical data management, statistical programming, and regulatory submission readiness.
This opportunity is suitable for professionals aiming to advance in:
Clinical Programming and Database Development
Medidata Rave Study Build and eCRF Design
Clinical Data Management (CDM)
SAS and SQL Programming for Clinical Trials
Regulatory-Compliant Data Systems (FDA, EMA, ICH-GCP)
Design, develop, validate, and maintain clinical trial databases using primary tools such as:
Medidata Rave
Oracle Inform / Oracle RDC
SAS
Supporting clinical data tools
Lead study build activities including:
eCRF design and configuration
Edit check programming
Custom function programming
Coding setup and configuration
Data import and export setup
Develop and maintain study documentation including specifications, validation documentation, and annotated CRFs.
Generate listings, reports, and custom outputs to support clinical study requirements.
Lead clinical programming activities across 3–10 concurrent studies depending on scope and complexity.
Coordinate programming deliverables with Data Managers, Project Analysts, Biostatisticians, and cross-functional teams.
Provide proactive updates to project management regarding risks to scope, timelines, or budget.
Participate in sponsor audits and support in-progress audits.
Contribute to study budget reviews and manage scope changes and change orders when required.
Serve as subject matter expert for core clinical systems including:
Medidata Rave
Oracle Inform / RDC
SAS
Reporting and migration tools
Perform system integration activities, application updates, and user acceptance testing.
Monitor applications for workflow alerts, system errors, and performance issues.
Provide second-tier technical support to clinical programming and data management teams.
Deliver senior-level review of study-level and multi-study deliverables to ensure data integrity and regulatory compliance.
Provide training, mentorship, and technical guidance to junior programmers.
Contribute actively to project meetings and departmental reviews.
Maintain updated knowledge of clinical programming trends, regulatory standards, and emerging technologies.
Minimum 5+ years of hands-on experience in Clinical Programming, with strong expertise in Medidata Rave study build and advanced configuration activities.
Proven experience in:
eCRF design
Edit check programming
Custom function development
Database migration and validation
Experience managing multiple concurrent clinical studies.
Prior exposure to sponsor audits and regulatory inspections preferred.
Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related discipline.
Advanced certifications are preferred but not mandatory.
Certified Clinical Data Manager (CCDM)
SAS Certified Professional or equivalent
Advanced proficiency in Medidata Rave Clinical Programming.
Strong programming skills in SAS, SQL, or R.
In-depth understanding of clinical database design and validation.
Experience with edit check development, coding dictionaries, and data integration workflows.
Strong knowledge of regulatory compliance standards (FDA, EMA, ICH-GCP).
Excellent analytical and problem-solving abilities.
Strong attention to detail and data accuracy.
Ability to manage multiple projects and prioritize effectively.
Strong written and verbal communication skills.
Ability to work independently and collaborate within global teams.
Hybrid work model based in Pune, India.
Exposure to global clinical trials and regulatory submission processes.
Opportunity to lead complex, multi-study clinical programming initiatives.
Performance-driven and innovation-focused environment within a global CRO.
This role provides strategic exposure to:
Clinical Data Systems Architecture
Advanced Study Build Leadership
Regulatory Submission Data Preparation
Cross-Functional Clinical Development Collaboration
Future career progression may include:
Lead Clinical Programmer
Clinical Programming Manager
Associate Director, Clinical Data Systems
Director, Clinical Data Management
Syneos Health has contributed to 94% of novel FDA-approved drugs and 95% of EMA-authorized products in recent years. With more than 29,000 professionals globally, the organization supports over 200 studies across 73,000+ clinical trial sites and hundreds of thousands of patients worldwide.
If you are an experienced Senior Clinical Programmer with Medidata Rave and SAS expertise, this hybrid opportunity in Pune offers leadership exposure in global clinical development programs.
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