Senior Manager, Clinical Systems Architecture

About This Role

This role involves directing the development of innovative clinical systems to transform Global Medical Affairs within BD, focusing on architecting object-focused clinical systems to simplify and enhance clinical operations and data management.

Responsibilities

• Identify and assess clinical system procurements, enhancements, and interoperability to harmonize data flow from NPD to commercialization
• Streamline clinical operations and achieve a continual state of inspection readiness
• Lead strategic and collaborative partnerships with external service providers and key stakeholders
• Pioneer transformational projects focusing on automation, improved workflows, and interoperability
• Consult and collaborate with SMEs to build bi-directional data connections and object-based configurations
• Partner with clinical quality and compliance to leverage clinical system design to mitigate risk and ensure audit readiness
• Drive master data cleanup to unify clinical data capture and reduce manual entry
• Oversee end-to-end clinical system functions, including planning, design, configuration, and day-to-day management
• Be a key partner in the development of Global Clinical Affairs’ digital strategy and technology roadmaps
• Drive clinical system team process optimization and ensure projects meet industry standards and regulations

Requirements

• Bachelor’s degree
• Veeva Vault Platform Certified White Belt (minimum of 500 hours of direct experience architecting, implementing, and managing clinical systems)
• Project Management Professional certification
• Direct experience managing clinical trials
• 5+ years of proven experience in clinical operations
• 5+ years of proven experience in clinical system architecture and management
• Expert-level proficiency in configuring and architecting all facets of Veeva systems
• Experience in performing data transformations using business intelligence tools (e.g., Power Query)
• Strong familiarity with APIs, including creating and managing API collections, running tests, and understanding JavaScript and JSON for interacting with and analyzing API data
• Advanced knowledge of HIPAA
• Advanced knowledge of GDPR
• Knowledge of 21 CFR Part 11
• Knowledge of ICH-GCP guidelines
• Knowledge of DIA TMF Reference Model
• Knowledge of GAMP 5
• Knowledge of SDLC

Qualifications

• Bachelor’s degree
• 5+ years of proven experience in clinical operations and 5+ years in clinical system architecture and management

Skills

* Required skills

Benefits

Certifications