Executive Director, Data & Technology Site & Study Start Up

Parexel•Southport, NC

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do. Job Title: Executive Director, Data & Technology Site & Study Startup Support Job Purpose: 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. Who we are looking for: We’re looking for a dynamic, forward‑thinking innovator with hands‑on experience in clinical operations technology who’s ready to elevate how studies get started and executed. You thrive at the intersection of feasibility, regulatory workflows, submissions, and site activation and you know these processes inside and out. You’ve led the charge on implementing enterprise clinical systems, driving seamless cross‑functional integrations, and ensuring data flows effortlessly across the clinical ecosystem.

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, Stie 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.

Nice To Haves

Master’s degree or equivalent experience preferred.

Responsibilities

Technology & Process Leadership 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
Enablement of Feasibility, Site Identification & Country Strategy 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.
Integration of Workflows with Operational, Regulatory & Clinical Systems 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
Operational Reporting, Data Quality & Predictive Insights 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.
System Lifecycle Ownership for SSU Platforms 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.
Leadership, Strategy & Organizational Enablement 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.