Senior Principal Clinical Programmer (Medidata RAVE)
Location: Hyderabad, India (Hybrid)
Job ID: 25106543
Employment Type: Full-Time
Experience Level: Senior Principal / Leadership
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success across the drug development and commercialization continuum. Through innovative clinical, medical affairs, and commercial solutions, Syneos Health partners with pharmaceutical, biotechnology, and healthcare organizations worldwide to bring life-changing therapies to patients faster.
With over 25,000 professionals globally, Syneos Health fosters a culture of collaboration, innovation, and continuous learning while delivering impactful healthcare solutions.
Position Summary
The Senior Principal Clinical Programmer (Medidata RAVE) serves as a strategic technical leader within Clinical Programming and Data Management, responsible for managing and supporting all programming activities across individual studies, complex programs, and enterprise-level initiatives.
This role provides advanced expertise in Electronic Data Capture (EDC) systems, database programming, clinical data processing, and application administration, with a strong focus on Medidata RAVE and related clinical technologies.
The successful candidate will lead clinical programming strategy, oversee complex deliverables, mentor programming teams, manage vendor relationships, and drive technical innovation while ensuring high-quality, compliant, and efficient study execution.
Key Responsibilities
Clinical Programming Leadership
Serve as Lead Clinical Programmer across single studies and large multi-study programs.
Develop and execute programming strategies to support clinical development activities.
Manage multiple projects, timelines, priorities, and deliverables simultaneously.
Identify operational trends across programs and implement continuous improvement initiatives.
Provide leadership and guidance to junior, senior, and lead clinical programmers.
EDC & Clinical Systems Expertise
Act as Subject Matter Expert (SME) for:
Medidata RAVE
Oracle Clinical (OC)
Oracle RDC
Oracle InForm
SAS
Clinical Reporting Platforms
Data Integration Tools
Support implementation, configuration, maintenance, and optimization of clinical systems.
Provide advanced technical support across Clinical Programming and Data Management functions.
Lead system upgrades, migrations, integrations, and enhancement initiatives.
Database Development & Validation
Design, develop, validate, and maintain clinical databases and supporting applications.
Oversee:
Database build activities
Edit check programming
Data validation procedures
Data import/export processes
Coding setup and management
Custom reporting solutions
Ensure compliance with sponsor requirements, regulatory standards, and internal SOPs.
Clinical Data Processing & Reporting
Develop and maintain:
Annotated CRFs (aCRFs)
Programming specifications
Data processing documentation
Validation documentation
Study listings and custom reports
Support data review, cleaning, reconciliation, and reporting activities.
Ensure data integrity, quality, and audit readiness throughout study lifecycles.
Application Administration & Technical Support
Provide administration and operational support for clinical applications.
Monitor internal and externally hosted systems for:
Workflow alerts
Performance issues
System errors
Security and access concerns
Troubleshoot programming and application defects.
Coordinate issue resolution with internal teams and external vendors.
Vendor & Stakeholder Management
Manage relationships with external application vendors and technology partners.
Support:
Vendor implementations
System integrations
Technology assessments
Issue escalation and resolution
Collaborate with sponsors, project teams, and cross-functional stakeholders to ensure successful study delivery.
Quality & Compliance
Ensure all programming activities comply with:
ICH-GCP Guidelines
Regulatory Requirements
Computer System Validation (CSV) Standards
Internal SOPs and Work Instructions
Participate in sponsor audits, inspections, and quality reviews.
Drive risk mitigation and quality improvement initiatives.
Team Leadership & Mentorship
Mentor and develop clinical programming staff.
Provide technical oversight and review of programming deliverables.
Support onboarding and training initiatives.
May provide direct supervisory responsibility for Lead Clinical Programmers and project teams.
Promote knowledge sharing and technical excellence across the organization.
Required Qualifications
Education
Bachelor's degree in:
Computer Science
Information Technology
Life Sciences
Pharmacy
Statistics
Mathematics
Related Scientific Discipline
Preferred:
Master's degree or equivalent advanced qualification.
Experience
Required
Extensive experience in:
Clinical Programming
Clinical Data Management
Electronic Data Capture (EDC) Systems
Clinical Systems Administration
Significant hands-on experience with:
Medidata RAVE
Clinical Database Development
Edit Check Programming
Clinical Reporting
Data Validation
Proven experience leading large clinical programs and cross-functional initiatives.
Preferred
Experience supporting global clinical trials across multiple therapeutic areas.
Vendor management and system implementation experience.
Team leadership and people management experience.
Exposure to database migration and integration projects.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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New Hampshire |Oklahoma :
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Washington |Delaware :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Koropi | Athens |Greece :
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Manila |Croatia :
Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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