Care Access is looking for a Director/Senior Director Site Excellence to own the strategy, design, and delivery of operating models for specialized, non-traditional, and partner-operated clinical research sites across the United States. This senior role requires a leader who can set high-level strategy and remain deeply hands-on in execution and problem-solving.
What You'll Do
- Own the end-to-end strategy, operating model, and performance of US-based specialized and franchise clinical research sites.
- Serve as the primary owner for building and operationalizing processes across site startup, enrolment, performance management, quality oversight, and partner engagement.
- Engage directly with sites and partners to assess operations, diagnose issues, and drive rapid resolution.
- Lead critical initiatives personally until they are stable, scalable, and ready for delegation.
- Act as the senior escalation point for complex operational, regulatory, and partner challenges.
- Oversee site startup, onboarding, and integration for new specialty site models.
- Build and embed operational excellence frameworks informed by best practices from high-performing sites.
- Establish KPIs, dashboards, and review cadences to monitor performance across quality, enrolment, timelines, cost, and patient experience.
- Drive continuous improvement initiatives to enhance efficiency, scalability, and operational resilience.
- Serve as the executive owner for partner site relationships, ensuring alignment with quality standards, brand expectations, and contractual obligations.
- Lead senior-level engagement with sponsors, CROs, and internal stakeholders tied to partner and specialized sites.
- Translate protocol, sponsor, and regulatory requirements into practical, scalable guidance for site execution.
- Ensure all sites operate in compliance with GCP, FDA regulations, IRB requirements, and applicable state and federal laws.
- Partner with Quality, Compliance, and Legal teams to proactively identify and mitigate operational and regulatory risks.
- Oversee audit readiness, inspection outcomes, and corrective/preventive action plans across the portfolio.
- Own P&L performance for specialized and partner site operations.
- Partner with Finance to build budgets and forecasts.
- Identify opportunities for sustainable growth, margin improvement, and cost optimization.
What We're Looking For
- Bachelor’s degree required.
- 12–15+ years of progressive leadership experience in clinical research operations, site management, or healthcare services.
- Demonstrated success building and scaling non-traditional, partner-led, or complex site operating models.
- Proven ability to operate as both strategist and hands-on operator in high-growth or ambiguous environments.
- Deep understanding of site-level execution: startup, enrolment, regulatory processes, sponsor engagement, and remediation.
- Strong working knowledge of FDA regulations, GCP, and clinical trial operations.
- P&L ownership experience across multi-site portfolios.
- Exceptional executive communication, influence, and change-management skills.
Nice to Have
- Advanced degree (MBA, MPH, MS, or similar) strongly preferred.
- Experience standing up sites or operational excellence functions.
- Background in decentralized or innovative clinical trial delivery models.
- Experience operating in matrixed, global organizations.
Team & Environment
You will build and lead a high-performing leadership team responsible for site operations and operational excellence.
Benefits & Compensation
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
Work Mode
This is a global role based in the United States.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
