Non Interventional Studies - Sr. Clinical Lead/ Sr. Clinical Trial Manager
Core
Manage clinical operational and quality aspects of moderate to high complexity studies to achieve clean data deliverables within contractual timelines.
Role type
Senior Clinical Trial Manager (Non-Interventional Studies)
Builds
Clinical study deliverables (clean data) for customers
Domain
Life Sciences / Clinical Research / Non-Interventional Studies
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical monitoring, ICH GCP compliance, resource management, budgeting and forecasting, regulatory submissions, risk management, team leadership, project tracking
Preferred skills
Process improvement, accompanied field visits, bid defense preparation
Technologies
Outlook, Excel, Word, automated clinical systems
Responsibilities
Manage clinical operational and quality aspects of allocated studies; Develop clinical tools (Monitoring Plan, Guidelines) and Trial Master File sections; Coordinate start-up activities and regulatory submissions; Monitor clinical trials performance and manage CRF collection/query resolution; Communicate with study sites on protocol and patient participation issues; Manage clinical resources and project financials.
Seniority
Senior, hands-on IC with potential regional lead responsibilities
