Parexel is looking for changemakers who are driven by curiosity, passion, and optimism. The Executive Director, D&T Site & Study Startup Support serves as the senior technology and data leader, partnering with Parexel’s global Site & Study Startup organization to ensure efficient, reliable, and compliant technology and data capabilities.
Responsibilities:
- Serve as the primary D&T executive partner for the global Site & Study Startup function, ensuring alignment to operational processes and startup lifecycle needs
- Drive system enhancements that improve startup predictability, data capture, cycle times, and risk identification
- Use innovative technology to improve effectiveness and efficiency of the business
- Partner with business leaders to ensure systems availability and support:
- Feasibility modeling
- Country and site selection
- Document collection and workflows
- ICF customization
- EC/RA/MoH submissions
- SIV scheduling and activation readiness
- Provide technology, analytical models, and data tools for feasibility assessments, including site intelligence, enrollment scenario modeling, and country strategy inputs
- Ensure real‑time access to feasibility insights, performance history, and site data across data platforms
- Oversee integrations between Site & Study Startup systems and broader D&T ecosystem systems
- Coordinate with regulatory and compliance technology partners to ensure consistent data flows into the broader D&T architecture
- Ensure end‑to‑end system readiness and integration for:
- Regulatory document management
- Site regulatory package preparation
- Greenlight/activation processes
- System setup and training workflows
- Build and scale reporting capabilities that measure startup progress, activation risks, feasibility metrics, and regulatory timelines
- Partner with Data Aggregation & Reporting and Data Governance teams to ensure consistent definitions and quality of clinical operational data
- Introduce predictive analytics to identify bottlenecks and propose mitigation before they impact activation
- Govern upgrades, enhancements, compliance validation, testing, and UAT for systems such as feasibility tools, regulatory workflow systems, site activation trackers, and training/access workflows
- Ensure systems meet GxP relevance expectations when applicable, using validation frameworks from the broader D&T quality ecosystem
- Lead a global team of product owners, business analysts, solution architects, and technologists supporting Site & Study Startup systems and processes
- Collaborate with D&T and business leaders to strengthen business automation and capabilities
- Drive operational excellence, customer focus, and continuous improvement across the organization
Requirements:
- Deep knowledge of site and study startup processes (feasibility, submissions, activation, regulatory workflows)
- Strong understanding of clinical operational systems and data flows
- Expertise delivering technology solutions in regulated clinical research environments
- Executive‑level communication, influence, and cross‑functional leadership
- Ability to translate operational challenges into system and data improvements
- 15+ years of experience in clinical operations technology, Site & Study Startup processes, feasibility, regulatory workflows, or related domains
- Experience implementing enterprise clinical systems and managing cross‑functional integrations
- Proven ability leading global, matrixed technology or operational teams
- Bachelor's degree in Life Sciences, Engineering, Business, or related discipline required
- Master's degree or equivalent experience preferred