Senior Director, Clinical Operations Business & Excellence
Core
Lead a centralized Clinical Operations Business Office to establish inspection readiness, govern vendor relationships, and optimize trial execution processes across the clinical portfolio.
Role type
Senior Director, Clinical Operations Business & Excellence
Builds
Centralized Clinical Operations Business Office, vendor governance frameworks, inspection readiness programs, and operational standards.
Domain
Clinical Trials / Life Sciences
Required skills
Strategic planning, vendor governance, contract negotiation, risk management, quality assurance, process improvement, cross-functional leadership, financial management, digital enablement, stakeholder alignment
Preferred skills
Experience with ICH-GCP E6(R3), knowledge of clinical trial master file (TMF) systems, expertise in centralized monitoring oversight, ability to lead organizational change
Technologies
eTMF systems, analytics dashboards, automation tools, collaboration platforms
Responsibilities
Define and lead the Business Office operating model and roadmap; oversee vendor governance and site contracting workflows; manage trial master file governance and inspection readiness; establish risk-based quality management standards; drive digital enablement and process improvements; lead cross-functional collaboration and strategic decision-making
Seniority
Senior Director, strategic leadership with hands-on execution
