Director, Clinical Data Platform & Integration Excellence

Alzheon, Inc.; Framingham, Northern (MA, KY); Hybrid; USD 180,000 - 280,000; Full time

Job summary

Alzheon, Inc. seeks a Director, Clinical Data Technology to own the study platforms and data flows for trials from start-up through archiving. You will be the technical product owner for the EDC system and related platforms, ensuring a single, validated environment across Clinical Ops, Data Management, and IT.

The role focuses on platform ownership, integration, operational reliability, and inspection readiness, collaborating with CROs and vendors globally.

Qualifications

• Degree in life sciences, computer science, information systems, engineering, or a related field.
• 8+ years with clinical trial systems, clinical data flows, or clinical technology delivery.
• Hands-on expertise with Medidata Rave or a comparable EDC ecosystem.
• Experience leading implementations, integrations, UAT, vendor oversight, issue resolution, and change control.

Responsibilities

• Define the study technology architecture and roadmap from start-up through lock, submission, and archiving.
• Serve as business and technical owner for Medidata, RTSM, eCOA/ePRO, eConsent, coding, laboratory, imaging, safety, and related systems.
• Translate protocol requirements into platform capabilities, configurations, interfaces, controls, and support plans.
• Lead configuration, integration, validation, UAT, release readiness, and go-live planning.
• Review specifications, data-transfer agreements, access models, and environment strategies.
• Coordinate cross-vendor testing as an end-to-end workflow.
• Own data-flow diagrams, interface inventories, transfer schedules, acknowledgments, reconciliation points, and versioning.
• Partner with Data Engineering and Data Management to ensure complete, traceable, timely delivery.
• Resolve gaps where a sender reports delivery but a receiving system did not ingest or expose data.
• Monitor platform health, transfer status, defects, access exceptions, releases, and service performance.
• Lead technical governance, risk reviews, change control, and vendor escalation.
• Maintain inspection-ready validation, access, issue, change, continuity, and decommissioning records.

Skills

Clinical trial systems

Medidata Rave

Vendor oversight

UAT

Data integration

Education

Degree in life sciences, computer science, information systems, or engineering

Tools

Medidata Rave

Job description

Alzheon, Inc. seeks a Director, Clinical Data Technology to own the study platforms and data flows for trials from start-up through archiving. You will be the technical product owner for the EDC system and related platforms, ensuring a single, validated environment across Clinical Ops, Data Management, and IT.

The role focuses on platform ownership, integration, operational reliability, and inspection readiness, collaborating with CROs and vendors globally.