We are seeking a Principal Clinical Database Programmer to lead the design, development, configuration, validation, and maintenance of clinical event and Serious Adverse Event (SAE) adjudication solutions within the Medidata ecosystem.

The role requires strong Medidata Rave EDC programming expertise and hands-on experience translating adjudication charters into secure database workflows. The successful candidate will configure Medidata Adjudicate or develop approved custom integrations and extensions, collaborating with Clinical Data Management, Clinical Operations, Pharmacovigilance, Clinical Event Committees (CEC), sponsors, and technology vendors.

Key Responsibilities

Database Design and Medidata Integration

- Lead the technical design of adjudication databases and SAE adjudication modules aligned with study protocols, endpoint definitions, adjudication charters, and the Medidata platform architecture.
- Develop electronic forms, edit checks, event identification rules, and programming specifications within Medidata Rave EDC.
- Implement study-specific triggers for adjudication case creation based on approved criteria, such as seriousness indicators, toxicity grades, or event outcomes.
- Design and validate data mappings and transfers for demographics, medical history, laboratory results, and AE/SAE records, minimizing duplicate data entry.
- Use supported Medidata interfaces, including Rave Web Services (RWS), where appropriate for scheduled or event-driven integrations.
- Collaborate with safety teams on Medidata Safety Gateway mappings, transmission rules, and reconciliation where required by the study architecture.

Dossier Preparation and Document Management

- Configure workflows for collecting, organizing, and versioning adjudication dossiers, including medical records, narratives, laboratory reports, and supporting documents.
- Implement and validate PHI redaction and document quality checks before materials are released to reviewers.
- Support PDF and medical imaging workflows, including DICOM and Medidata imaging integrations where required and supported.
- Ensure dossier completeness, traceability,



and controlled access throughout the review lifecycle.

Clinical Event Committee Workflows

- Configure reviewer assignments, independent assessments, double-review, triple-review, and consensus workflows according to the adjudication charter.
- Implement role-based permissions and blinding controls to protect treatment information and independent reviewer decisions.
- Develop discordance rules, notifications, and escalation pathways for tie-breaker or committee chair review.
- Configure comparison views for site-reported data, narratives, and reviewer assessments, with visibility controlled by the review stage and charter.
- Maintain traceability between source events, adjudication cases, reviewer decisions, and final outcomes.

Queries, Tracking, and Data Delivery

- Design query workflows for obtaining clarification or missing information from sites and study teams.
- Implement and validate bidirectional query synchronization with Rave EDC where supported by the approved integration.
- Develop reports and dashboards for case status, overdue reviews, outstanding queries, discordance, and reconciliation.
- Implement reliable saving, recovery, and timestamped audit trails for data changes, document revisions, workflow transitions, and adjudication decisions.
- Reconcile adjudication data against EDC and safety data, investigating discrepancies with the relevant teams.
- Support database lock, final adjudication data exports, downstream analysis deliverables, and archival.

Validation and Technical Leadership

- Prepare technical specifications, test scripts, validation documentation, and change-control records.
- Lead technical testing and support user acceptance testing, including integration, access-control, blinding, and workflow testing.




- Assess database amendments and implement approved changes with appropriate impact assessment and regression testing.
- Work with quality and validation teams to meet applicable GCP, electronic-record, privacy, and company requirements.
- Troubleshoot complex technical issues, review programming deliverables, and mentor other programmers.
- Develop reusable standards and components to improve quality and delivery efficiency across studies.

Required Qualifications

- Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related discipline, or equivalent relevant experience.
- Typically 8 or more years of clinical database programming experience, including technical leadership responsibilities.
- Strong hands-on experience with Medidata Rave EDC database builds, electronic forms, edit checks, and validation.
- Demonstrated experience building or configuring clinical event or SAE adjudication databases.
- Experience with Medidata Adjudicate or comparable adjudication platforms integrated with Rave EDC.
- Strong understanding of CEC workflows, adjudication charters, independent review, blinding, discordance resolution, and consensus processes.
- Experience with APIs or web services, data mapping, clinical system integrations, and reconciliation.
- Proficiency in SQL and relevant programming or scripting languages.
- Experience with dossier management, PHI redaction workflows, role-based access, and audit trails.
- Robust documentation, troubleshooting, communication, and stakeholder management skills.
- Ability to manage multiple studies and deliver high-quality work within agreed timelines.

Preferred Qualifications

- Direct experience configuring Medidata Adjudicate.
- Hands-on experience with Medidata Rave Web Services.
- Experience with Medidata Safety Gateway and ICH E2B(R2/R3) data mappings.
- Experience with Medidata imaging solutions or DICOM workflows.
- Familiarity with CDISC standards and adjudication data delivery for statistical analysis.
- Experience developing reusable adjudication frameworks and leading complex global study builds.

📌 Principal Clinical Database Programmer (Adjudication Module) (India)
🏢 Tech Observer
📍 India