Note: The job is a remote job and is open to candidates in USA. CRIO is a leading provider of eSource solutions for clinical research, and they are seeking a Senior Director of Sponsor Operations to build and lead their enterprise sponsor business. This role is responsible for overseeing the entire sponsor lifecycle, ensuring high-quality delivery and compliance across programs while collaborating with various departments to align sponsor needs with CRIO's capabilities.
Responsibilities
- 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
- 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
- Serve as senior leadership point of contact for sponsor organizations
- Lead high level sponsor discussions related to scope, timelines, data expectations, and escalations
- 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
- Oversee the alignment of eSource data with EDC systems, ensuring accurate, complete, and compliant data transfer
- 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
- 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
- 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
- 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
Skills
- 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
- Proven 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
- 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
Benefits
- Work from anywhere
- Unlimited PTO
- 401k company match
- Healthcare
- Dental
- Vision (Company Paid 100%)
- Life insurance
- Professional development
- Work From Home Expense Reimbursement
Company Overview