Director, Clinical Data Platform & Integration Excellence

Alzheon, Inc.; Framingham (MA); Hybrid; USD 180.000 - 280.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Clinical trial systems

Medidata Rave

Vendor oversight

UAT

Data integration

Ausbildung

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

Tools

Medidata Rave

Jobbeschreibung

• Location On-Site or Hybrid (Framingham, MA)

Company Overview

Alzheon, Inc. is a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease and other neurodegenerative disorders. We are committed to developing innovative medicines by directly addressing the underlying pathology of devastating neurodegenerative disorders. Our lead Alzheimer’s clinical candidate, ALZ-801 , is an oral agent in Phase 3 development as a potentially disease modifying treatment for AD. ALZ-801 is an oral small molecule that fully blocks formation of neurotoxic soluble amyloid oligomers in the brain. Our clinical expertise and technology platform are focused on developing drug candidates and diagnostic assays using a precision medicine approach based on individual genetic and biomarker information to advance therapies with the greatest impact for patients.

Our experienced and passionate drug development team is focused on applying precision medicine, cutting-edge disease biomarkers, brain imaging and unique biologic insights to advance therapies with the greatest impact for patients. We are seeking individuals with an entrepreneurial spirit to join our team and help make the first oral Alzheimer’s disease-modifying therapy a reality for patients and their families, in a few short years.

Position Overview

Alzheon is seeking a clinical technology leader to serve as Clinical Data Technology Lead, owning the study platforms, integrations, and data flows that carry a trial from start-up through database lock, submission, and archiving. You will be the technical product owner for our EDC and the systems that surround it, and you will be accountable for making that collection of platforms behave like one reliable, secure, validated environment rather than a set of separate tools.

The work sits between Clinical Operations, Clinical Data Management, Data & AI, Quality, IT and Security, and our study vendors. The focus is platform ownership, integration, day-to-day operational reliability, and oversight that holds up in an inspection.

Key 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

Requirements

• 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

Preferred Qualifications

• Experience with RTSM, eCOA/ePRO, eConsent, coding, safety, imaging, laboratory, and biomarker integrations
• Knowledge of CDISC, RBQM, computerized-system validation, submission readiness, and inspection support
• Experience in global Phase 3 studies with multiple CROs and specialty vendors

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

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