Clinical Trial Manager/ Sr. Clinical Trial Manager - FSP client dedicated
Core
Manage clinical operational and quality aspects of moderate to high complexity studies to achieve final clean data deliverables within contractual timelines.
Role type
Senior Clinical Trial Manager (IC)
Builds
Clinical study deliverables (clean data, TMF, regulatory submissions) for pharmaceutical/biotech clients
Domain
Clinical Research / Life Sciences
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, risk management, regulatory submissions, team leadership, project coordination
Preferred skills
Lead CTM/CSM responsibilities, process improvement, accompanied field visits (AFVs), 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; Provide input into forecast estimates for clinical activities.
Seniority
Senior, hands-on IC with potential regional lead responsibilities
