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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. This role ensures that business teams are fully enabled with efficient, reliable, and compliant technology, data, systems, and process capabilities. This leader ensures optimized delivery of startup activities, higher predictability of activation timelines, improved data quality, and robust operational systems across feasibility, regulatory submissions, site activation, and early‑study operational readiness.
Job Responsibility:
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 for 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
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
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
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
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:
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
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
What we offer:
Health, Vision & Dental Insurance
Tuition Reimbursement
Vacation/Holiday/Sick Time
Flexible Spending & Health Savings Accounts
Work/Life Balance
401(k) with Company match
Pet Insurance
Opportunity to work on innovative projects at the forefront of the industry
Collaborative and inclusive work environment that values your expertise
Professional advancement and development opportunities