Manager Clinical Systems Veeva
Remote Manager, Clinical Systems Veeva
Salary: $150,000-190,000 base salary
Clinical Systems
The Clinical Systems function is responsible for enabling scalable, inspection‑ready clinical systems that support the full lifecycle of product development through commercialization. This team leads the design, implementation, and strategic evolution of clinical systems to improve efficiency, automation, interoperability, and data integrity. The mission is to streamline clinical operations, optimize trial execution, and ensure harmonized, compliant data across global programs-allowing clinical teams to focus on delivering high‑quality evidence and accelerating time to market.
Position Summary
This role serves as a key partner in advancing Global Medical and Clinical Affairs by architecting and delivering innovative, interoperable clinical systems that support robust evidence generation. The Manager, Clinical Systems will lead the design, configuration, and ongoing optimization of object‑based clinical systems-primarily within the Veeva Vault platform-to simplify clinical operations, improve data flow, and enhance inspection readiness.
Key Responsibilities
- Architect and deliver scalable, future‑state clinical systems supporting new product development through commercialization, with a strong focus on inspection readiness
- Lead the architecture, implementation, and ongoing management of global clinical systems, ensuring alignment with timelines, budgets, and business requirements
- Provide thought leadership in the evolution of clinical system capabilities, driving efficiency through automation, interoperability, and enhanced analytics
- Act as a strategic liaison between clinical study teams and clinical systems to optimize trial execution and reduce cycle times
- Assess and guide clinical system procurements, enhancements, and integrations to ensure harmonized data flow across platforms
- Serve as a change agent by leading transformational initiatives focused on workflow optimization, automation, and interoperable system design
- Collaborate with subject matter experts to design bi‑directional data integrations and object‑based configurations using vendor best practices
- Partner closely with quality and compliance stakeholders to mitigate risk and maintain continuous audit and inspection readiness
- Lead communication and engagement strategies to drive end‑user adoption and stakeholder alignment
- Drive master data standardization and cleanup, replacing manual data entry with automated, interoperable data connections where possible
- Oversee end‑to‑end clinical system activities including planning, design, configuration, validation, change control, and day‑to‑day operations
- Contribute to the development of clinical digital strategy and multi‑year technology roadmaps
- Optimize team processes to increase use of APIs, data loaders, and business logic for scalable data creation and maintenance
- Ensure systems and processes meet applicable regulatory and industry standards through strong controls, documentation, and a quality‑focused culture
- Lead continuous improvement efforts, establish best practices, and enforce standardization where appropriate
- Provide guidance, mentoring, and technical leadership to cross‑functional clinical and technology colleagues
Qualifications
Education & Experience
- Bachelor's degree required
- Veeva Vault Platform Certified (White Belt required) with a minimum of ~500 hours of hands‑on experience architecting, implementing, and managing clinical systems
- Direct experience supporting clinical trials
- 3+ years of experience in clinical operations
- 3+ years of experience in clinical systems architecture, implementation, and management
Technical Expertise
- Advancedhands‑on experience configuring andarchitectingVeeva Vault systems, including:
- Security models, documents, objects, lifecycles, workflows, reporting, VQLs, and integrations (Vault‑to‑Vault and external)
- Strong experience with APIs, including building and managing API collections, testing, and working with JavaScript and JSON
- Experience performing data transformation and analysis using business intelligence or data preparation tools (e.g., Power Query)
- Proven ability to design interoperable, object‑based system architectures aligned with vendor best practices
Regulatory & Compliance Knowledge
- Strong working knowledge of global privacy and regulatory standards, including:
- HIPAA, GDPR
- 21 CFR Part 11
- ICH‑GCP
- DIA TMF Reference Model
- GAMP 5
- SDLC principles
Leadership Competencies
- Strategic, systems‑level thinker with the ability to translate business needs into scalable technical solutions
- Strong stakeholder management and communication skills across clinical, quality, IT, and vendor partners
- Demonstrated ability to lead change, influence without authority, and drive adoption in matrixed environments
- Hands‑on leader with a quality‑first mindset and a passion for continuous improvement
FAQs
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