Parexel Logo

Parexel

Executive Director, Data & Technology Site & Study Start Up

Reposted 7 Hours Ago
Be an Early Applicant
Remote
Hiring Remotely in United States
Expert/Leader
Remote
Hiring Remotely in United States
Expert/Leader
The Executive Director leads technology and data initiatives for Site & Study Startup, enhancing operational efficiency and compliance in clinical trials.
The summary above was generated by AI

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.

What you’ll do:

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.

    Skills:

    • 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.

    Knowledge and Experience:

    • 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.

    Education:

    • Bachelor’s degree in Life Sciences, Engineering, Business, or related discipline required.
    • Master’s degree or equivalent experience preferred.

    Why join us:

    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.

    Work life balance and flexible working hours.

    Parexel US Benefits:

    • 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

    Full list of benefits available here: https://www.parexel.com/us-benefits

    About Parexel International:

    At Parexel we embrace flexibility and understand that in today’s fast-paced world, employees need to balance their careers with their personal lives. Come join us where learning is constant, you are exposed to a world of experiences and open doors. 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 are committed to making a difference.

    If this job does not sound like the next step in your career, but perhaps you know of someone who’d be a perfect fit, please share the job posting link to apply!

    EEO Disclaimer
    Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

    Top Skills

    Clinical Operations Technology
    Data Tools
    Enterprise Clinical Systems
    Regulatory Workflows

    Similar Jobs

    5 Minutes Ago
    In-Office or Remote
    Indianapolis, IN, USA
    37K-37K Hourly
    Mid level
    37K-37K Hourly
    Mid level
    Manufacturing
    As a Product Consultant, you will provide outstanding customer service, diagnose issues, manage calls, and maintain documentation while meeting daily performance metrics.
    Top Skills: MS OfficeMicrosoft Teams
    6 Minutes Ago
    Easy Apply
    Remote or Hybrid
    2 Locations
    Easy Apply
    145K-190K Annually
    Senior level
    145K-190K Annually
    Senior level
    Artificial Intelligence • Information Technology • Machine Learning • Natural Language Processing • Productivity • Software • Generative AI
    The Engagement Manager leads enterprise deployments of Superhuman's AI productivity platform, managing the project lifecycle from scoping to go-live, while collaborating with cross-functional teams and ensuring customer success.
    Top Skills: AsanaCodaConfluenceJIRAMiroMondayMs ProjectNotionSmartsheetWrike
    8 Minutes Ago
    Remote
    United States
    160K-225K Annually
    Senior level
    160K-225K Annually
    Senior level
    AdTech • Digital Media • eCommerce • Marketing Tech
    The Engineering Manager will lead software teams, oversee platform architecture and SDK development, ensuring high-quality and scalable software delivery while managing people and technical strategy.
    Top Skills: .NetAPIsAWSC#KafkaMicroservices

    What you need to know about the Austin Tech Scene

    Austin has a diverse and thriving tech ecosystem thanks to home-grown companies like Dell and major campuses for IBM, AMD and Apple. The state’s flagship university, the University of Texas at Austin, is known for its engineering school, and the city is known for its annual South by Southwest tech and media conference. Austin’s tech scene spans many verticals, but it’s particularly known for hardware, including semiconductors, as well as AI, biotechnology and cloud computing. And its food and music scene, low taxes and favorable climate has made the city a destination for tech workers from across the country.

    Key Facts About Austin Tech

    • Number of Tech Workers: 180,500; 13.7% of overall workforce (2024 CompTIA survey)
    • Major Tech Employers: Dell, IBM, AMD, Apple, Alphabet
    • Key Industries: Artificial intelligence, hardware, cloud computing, software, healthtech
    • Funding Landscape: $4.5 billion in VC funding in 2024 (Pitchbook)
    • Notable Investors: Live Oak Ventures, Austin Ventures, Hinge Capital, Gigafund, KdT Ventures, Next Coast Ventures, Silverton Partners
    • Research Centers and Universities: University of Texas, Southwestern University, Texas State University, Center for Complex Quantum Systems, Oden Institute for Computational Engineering and Sciences, Texas Advanced Computing Center

    Sign up now Access later

    Create Free Account

    Please log in or sign up to report this job.

    Create Free Account