What are the responsibilities and job description for the Clinical Systems Architect position at Emerald Advantage Concepts LLC?
About The Role
We are seeking a Manager of Clinical Systems Architecture to lead the design, implementation, and evolution of innovative, interoperable clinical systems that support global clinical operations and evidence generation. This role is a key partner in transforming clinical affairs by architecting scalable, inspection‑ready systems that streamline clinical trial execution and accelerate product development.
You will lead system strategy, architecture, configuration, and integration across clinical operations, data management, and quality teams—ensuring automation, interoperability, and compliance across the clinical systems ecosystem.
What You'll Do
Clinical Systems Architecture & Strategy
We are seeking a Manager of Clinical Systems Architecture to lead the design, implementation, and evolution of innovative, interoperable clinical systems that support global clinical operations and evidence generation. This role is a key partner in transforming clinical affairs by architecting scalable, inspection‑ready systems that streamline clinical trial execution and accelerate product development.
You will lead system strategy, architecture, configuration, and integration across clinical operations, data management, and quality teams—ensuring automation, interoperability, and compliance across the clinical systems ecosystem.
What You'll Do
Clinical Systems Architecture & Strategy
- Architect and deliver scalable, future‑state clinical systems supporting new product development through commercialization
- Lead system design, configuration, and lifecycle management across Global Clinical Affairs
- Drive automation, interoperability, and data harmonization across clinical systems
- Oversee planning, configuration, validation, and day‑to‑day management of clinical systems
- Identify system enhancements, integrations, and data flow improvements
- Build bi‑directional data connections and object‑based configurations using vendor best practices
- Drive master data cleanup and replace manual processes with automated, interoperable solutions
- Partner with clinical operations, quality, compliance, and external vendors
- Lead communication strategies to improve end‑user adoption and engagement
- Provide guidance and mentorship to cross‑functional teams
- Ensure systems meet regulatory standards: HIPAA, GDPR, 21 CFR Part 11, ICH‑GCP, GAMP 5
- Maintain audit readiness and support inspection‑ready clinical operations
- Lead change control, validation, and risk‑based system improvements
- Bachelor's degree
- Veeva Vault Platform Certified White Belt with 500 hours architecting and managing clinical systems
- 3 years of clinical operations experience
- 3 years of clinical systems architecture experience
- Direct experience supporting clinical trials
- Advanced configuration of Veeva Vault (security, objects, lifecycles, workflows, reporting, VQL, integrations)
- Strong API knowledge (collections, testing, JavaScript, JSON)
- Experience with data transformation tools (e.g., Power Query)
- Deep understanding of SDLC and clinical system validation
- Strong knowledge of privacy and regulatory frameworks:
- HIPAA
- GDPR
- 21 CFR Part 11
- ICH‑GCP
- DIA TMF Reference Model
- GAMP 5
- Lead clinical systems transformation for a global MedTech organization
- Architect next‑generation clinical systems that accelerate product development
- High visibility across clinical, quality, and digital strategy teams
- Culture of innovation, learning, and continuous improvement
- Onsite: 4 days per week
- Occasional travel
- Full‑time, direct hire