Study Start-up Manager
Core
Drive the planning and execution of clinical study start-up activities to ensure trials are launched efficiently, compliantly, and to the highest quality standards.
Role type
Senior clinical study start-up manager
Builds
Clinical trials
Domain
Biopharmaceuticals / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global team leadership, project management, risk assessment and mitigation, regulatory knowledge (ICH-GCP), resource management, cross-functional collaboration, continuous improvement
Preferred skills
Life sciences experience, global clinical trial team experience, risk-based monitoring, clinical site management, PMP certification
Technologies
Veeva
Responsibilities
Lead planning and delivery of clinical study start-up activities from global to local; Own and manage study start-up plans and milestones; Act as primary point of contact for cross-functional start-up teams; Identify, assess, and mitigate risks; Partner with Study Delivery Leads and local teams; Manage internal resources and external suppliers
Seniority
Senior, hands-on IC with management responsibilities
