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Senior Principal Clinical Programmer

Syneos Health
10+ years
Not Disclosed
Hyderabad
1 June 3, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

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