Global Study Assoc. Director - Single Sponsor Dedicated
Core
Lead cross-functional study teams to deliver clinical studies in the pharmaceutical industry, ensuring adherence to timelines, budget, and quality standards.
Role type
Senior Study Associate Director (Clinical Operations)
Builds
Clinical studies for life sciences and healthcare industries
Domain
Biopharmaceuticals / Clinical Research
Required skills
Clinical study management, Project management, Team leadership, Regulatory compliance (ICH-GCP), Vendor management, Budget management, Risk management, Quality assurance, TMF oversight, Audit/inspection readiness
Preferred skills
Medical or biological sciences background, Process improvement expertise, Subject Matter Expertise
Technologies
ACCORD, ABACUS, PharmaCM
Responsibilities
Lead and delegate to cross-functional study teams; Facilitate communication across functions and external partners; Develop study documents (Protocol to CSR); Ensure external service providers meet goals; Manage study budget and re-forecasting; Oversee performance against KPIs; Identify and report quality issues; Ensure inspection readiness; Provide performance feedback and mentor team members.
Seniority
Senior, hands-on IC with leadership responsibilities
