Senior Principal Clinical Programmer (Medidata Rave)
Location: Hyderabad, India
Work Mode: Hybrid
Department: Clinical Programming / Clinical Data Management
Job Overview
We are seeking an experienced Senior Principal Clinical Programmer (Medidata Rave) to provide advanced technical leadership across clinical programming operations and enterprise-level clinical data systems. This role is responsible for overseeing end-to-end clinical programming strategy, managing multi-study deliverables, ensuring system performance, and supporting EDC and clinical data processing platforms.
The position requires deep expertise in Medidata Rave, SAS programming, clinical database design, and clinical data management systems, along with strong leadership capabilities in managing large-scale clinical programs and cross-functional stakeholder engagement.
Key Responsibilities
Clinical Programming Leadership & Strategy
Serve as a senior-level clinical programming expert across multiple studies and programs.
Define and support overall clinical programming strategy across assigned portfolios.
Provide technical leadership and guidance to programming teams and stakeholders.
Identify operational trends across studies and implement improvements to optimize outcomes.
Medidata Rave & EDC Systems Management
Act as subject matter expert for Medidata Rave and other EDC platforms.
Design, develop, validate, and maintain clinical data capture and processing applications.
Support system configuration including:
CRF annotation and design support
Database build and setup
Edit check programming
Data import/export configurations
Custom reports and listings
Monitor system performance, workflow alerts, and technical issues proactively.
Clinical Data Programming & Development
Utilize SAS and other tools to develop and maintain clinical programming solutions.
Ensure accurate and efficient implementation of programming specifications.
Support data processing, validation, and reporting deliverables.
Maintain compliance with standard development procedures and regulatory requirements.
System Integration & Technical Support
Lead system integration activities across clinical data platforms.
Manage application updates, enhancements, and validation processes.
Conduct User Acceptance Testing (UAT) and ensure system readiness.
Troubleshoot system errors, performance issues, and technical defects.
Study and Program Oversight
Manage multiple concurrent studies and large-scale clinical programs.
Oversee timelines, deliverables, and resource allocation across projects.
Monitor project scope, identify risks, and manage change control processes.
Ensure alignment between study requirements and programming outputs.
Quality Assurance & Compliance
Provide senior-level review of program and study deliverables.
Ensure compliance with SOPs, regulatory guidelines, and internal quality standards.
Support sponsor audits and in-progress inspection activities.
Maintain inspection-ready documentation and validation records.
Stakeholder & Client Management
Act as primary programming representative in client and sponsor discussions.
Participate in bid defenses, project reviews, and senior management meetings.
Communicate project status, risks, and escalations effectively.
Collaborate with cross-functional teams to finalize technical specifications.
Leadership & Mentorship
Provide mentorship, training, and guidance to lead and junior clinical programmers.
Support skill development and technical capability building within the team.
Review work products and ensure adherence to quality standards.
Foster a high-performance and collaborative team environment.
Business & Change Management
Review project budgets, scope, and resource requirements.
Monitor project metrics and identify potential change orders.
Manage execution of change control processes and approvals.
Contribute to operational efficiency and process improvement initiatives.
Required Qualifications
Education
Bachelor’s or Master’s degree in Computer Science, Life Sciences, Statistics, Mathematics, Pharmacy, Biotechnology, or a related field.
Experience Required
Fresher Eligible: No
Required Experience: Minimum 10+ years of experience in Clinical Programming
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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Rangpo |India :
Remote, India | Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
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Brussels |Antwerp :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Remote Korea |Republic of Korea :
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Yavne | Be'Er Sheva | Tel Aviv | Kfar Saba | Netanya |Remote :
McFarland | Faridabad | Perth | Xzagreb | Remote - South America (Latin Americal) | Springville | Remote - Africa | Bountiful | Manipal | Nairobi | Hungary | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Middle East | Remote - Europe | Leinster | Minnesota | Belgium | Hammond | Riga | Zaragoza | Slovakia | Blue Bell | French | Tulsa | Texas | Lousiana | Medan | Ireland | Lenexa | Castlebar | Switzerland | Victoria | Melbourne | Thailand | Milwaukee | Bishop | Green Way |Republic of Colombia :
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King Abdullah Economic City | Jeddah | Rabigh | Najran | Khulais | Riyadh |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
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Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |