Sr. Manager, Study Start Up
Core
Leads global study start-up and site activation activities for Phase I-III and real-world evidence clinical trials, partnering with CROs and internal stakeholders to accelerate enrollment milestones.
Role type
Senior Manager, Clinical Operations (Study Start-up)
Builds
Global study startup plans, site activation strategies, and operational processes for clinical trials.
Domain
Biopharmaceuticals / Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global study start-up leadership, site activation management, CRO partnership management, data-driven enrollment forecasting, risk mitigation, project management, regulatory compliance (GCP), cross-functional team leadership
Preferred skills
Higher degree in Science, experience with Trial Delivery Optimization, expertise in country and site selection
Technologies
Clinical trial management tools, data analysis platforms, project management software
Responsibilities
Drive global study start-up and site activation activities and milestone oversight; Develop and deliver global study startup plans; Lead development of procedures to enhance internal start-up capabilities; Guide study teams through key startup activities within timelines; Oversee analysis of clinical trial data for accurate startup forecasts; Collaborate with Feasibility experts for data-driven planning; Develop creative processes and technologies for Study Startup Services; Participate in early global strategic study planning; Partner with CROs for efficient start-up processes; Work with internal teams to progress site activations and resolve roadblocks; Track and report KPIs including cycle times; Oversee application of study start-up standards; Support recruitment and performance of junior staff
Seniority
Senior, hands-on IC with management responsibilities
