Global Study Associate Director - Single Sponsor dedicated
Core
Lead cross-functional study teams to deliver clinical studies for biopharmaceuticals, ensuring adherence to timelines, budget, and quality standards.
Role type
Senior IC clinical study management lead
Builds
Clinical studies (non-drug projects)
Domain
Life Sciences / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study management, Project management, Team leadership, Regulatory compliance (ICH-GCP), Vendor oversight, Budget management, Risk management, TMF management, Audit readiness
Preferred skills
Medical or biological sciences background, Process improvement expertise, Subject matter expertise in study systems
Technologies
ACCORD, ABACUS, PharmaCM
Responsibilities
Lead and delegate to cross-functional study teams; Facilitate communication across functions and with external partners; Develop study-level documents (Protocol to CSR); Ensure external service providers meet goals; Manage study budget and re-forecasting; Oversee performance against KPIs; Ensure inspection readiness and manage audits; Provide performance feedback and mentor team members.
Seniority
Senior, hands-on IC
