Sr. CTM, FSP
Core
Manage clinical operational and quality aspects of moderate to high complexity studies to achieve final clean data deliverables within contractual timeframes.
Role type
Senior Clinical Trial Manager (IC)
Builds
Clinical study deliverables (clean data, documents, reports) for pharma/CRO clients
Domain
Clinical Research / Life Sciences
Required skills
Clinical monitoring, ICH GCP compliance, resource management, budgeting and forecasting, risk management, regulatory submissions, team leadership, project coordination
Preferred skills
Lead CTM or Clinical Study Manager experience, process improvement, accompanied field visits
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
