Sr. Director of Sponsor Operations

Position Summary

The Senior Director of Sponsor Operations is responsible for building, scaling, and leading CRIO’s enterprise sponsor business, including Central eSource programs across global pharmaceutical and CRO organizations. This role owns the end to end sponsor lifecycle from initial engagement through multi study execution and long term expansion.

Key Responsibilities

• Enterprise Sponsor Strategy and Growth

• Own the operational strategy for all enterprise sponsor programs including Lilly, ICON, Moderna, and future enterprise accounts
• Partner with Sales and Executive Leadership to support enterprise deal strategy, solution design, and expansion planning
• Define scalable Central eSource operating models across sponsor organizations
• Identify opportunities to expand sponsor adoption across additional studies, geographies, and use cases

• Sponsor Portfolio Ownership and Execution

• Own delivery across all active and planned studies within enterprise sponsor portfolios
• Ensure consistency in execution, timelines, and quality across all sponsor engagements
• Establish standardized workflows, templates, and delivery frameworks across sponsors
• Drive visibility through executive level reporting on portfolio health, risks, and performance
• Establish governance models for enterprise sponsor accounts including regular executive reviews and QBR structures
• Lead high level sponsor discussions related to scope, timelines, data expectations, and escalations

• Clinical Data Strategy and Oversight

• Own the clinical data framework for all sponsor programs, ensuring alignment with industry standards and sponsor expectations
• Oversee CDASH mapping, data structuring, and standardization across all studies
• Ensure consistency and quality of data capture, validation, and downstream usability
• Define and enforce data governance practices across sponsor portfolios
• Ensure integration outputs meet sponsor requirements for data quality, structure, and format
• Establish processes for Data review and validation, Query management alignment with sponsor workflows, XML and structured data output review

• Operational Architecture and Central eSource Design Alignment

• Oversee enterprise Central eSource design frameworks, ensuring alignment with sponsor protocols, regulatory requirements, and site workflows
• Define data capture logic, workflow structures, and role based access models across studies
• Drive standardization across study configuration, amendment processes, and UAT strategies
• Establish repeatable deployment models that balance flexibility with scalability
• Identify and champion opportunities to embed AI-driven automation across sponsor workflows, including Central eSource design configuration, data validation, query management, and amendment processing
• Partner with Product and Engineering to define enterprise requirements for AI-assisted capabilities, such as intelligent data capture, protocol deviation detection, and EDC integration quality checks
• Stay ahead of emerging AI applications in clinical data and eSource, translating sponsor needs and operational patterns into actionable input for CRIO's AI product roadmap

• Integration and Technical Delivery Alignment

• Partner with Product and Engineering to define and prioritize enterprise integration requirements across EDC, CTMS, eRegulatory, and external systems
• Ensure data integrity and consistency across all integration points
• Serve as executive escalation point for complex technical, data, and integration challenges

• Cross Functional Leadership and Alignment

• Lead coordination across Sponsor Operations, Central eSource design, Data Migration, Product, Engineering, and Customer Experience teams
• Ensure alignment between sponsor requirements and internal delivery capabilities
• Identify and resolve systemic gaps across workflows, data handling, and handoffs
• Partner with Product Leadership to influence roadmap priorities based on enterprise data and integration needs
• Drive accountability across all functions involved in sponsor delivery

Qualifications

• 10+ years of experience in clinical research technology, data management, sponsor operations, or clinical trial systems
• 5-7+ years of operational team and/or personnel management
• Strong background in clinical data management, including: CDISC standards (CDASH, USDM, SDTM, etc.), data mapping and transformation, data validation and quality processes
• Prominent experience managing enterprise sponsor or CRO relationships across multiple studies or programs
• Deep understanding of clinical trial workflows, site operations, and regulatory requirements
• Experience working with eSource, EDC, CTMS, or related clinical platforms
• Demonstrated ability to lead complex, data intensive, cross functional programs
• Exceptional communication and executive presence

Preferred

• Exposure with Central eSource concept models or similar sponsor site integrated workflows
• Familiarity with HL7 FHIR, API based integrations, or structured data exchange models
• Experience overseeing data migration or large scale data transformation initiatives
• Background in CRO, sponsor organization, or clinical technology vendor environment
• Prior experience scaling teams in a high growth environment