Manager, Study Start Up
Core
Manager leading study and site start-up operations to accelerate clinical trial execution and ensure operational excellence across all phases of clinical development.
Role type
Manager, Clinical Study Start-Up
Builds
Clinical trial study and site start-up deliverables
Domain
Biopharmaceuticals / Clinical Development
Required skills
Study start-up management, Clinical trial planning, Site activation, Regulatory compliance (ICH/GCP/EMEA), Project management, Data analysis, Budgeting and contract negotiation, Process improvement
Preferred skills
Veeva clinical solutions, Clinical data management, Clinical research organization (CRO) experience
Technologies
Veeva clinical solutions
Responsibilities
Drive study feasibility deliverables and provide data-driven recommendations to accelerate clinical trials; Engage with clinical study teams to generate best outcomes for start-up activities; Ensure adherence to standards for planning and execution of study start-up; Partner with Clinical Operations to ensure real-time collection of information for site identification and activation; Support execution of clinical trials from protocol concept to Site Activation; Monitor start-up metrics against KPIs; Develop site budgets and contracts; Create and manage central start-up team tools; Implement best study start-up practices and streamline workflows.
Seniority
Manager, hands-on IC