Non Interventional Studies - Sr. Clinical Lead/ Sr. Clinical Trial Manager
Core
Manage all clinical operational and quality aspects of allocated studies of moderate to high complexity to achieve final clinical deliverables within contractual time periods.
Role type
Senior Clinical Trial Manager (Sr. Clinical Lead)
Builds
Clinical study deliverables (clean data from evaluable patients) for customers
Domain
Clinical Research / Life Sciences
Required skills
Clinical monitoring, ICH GCP compliance, resource management, financial acumen, risk management, regulatory submissions, team leadership
Preferred skills
None stated
Technologies
Outlook, Excel, Word
Responsibilities
Manage clinical operational and quality aspects of allocated studies; Develop clinical tools (Monitoring Plan, Guidelines) and Trial Master File sections; Collaborate with clinical team and departments to meet project deliverables; Monitor clinical trials to assess performance and ensure contractual obligations; Coordinate start-up activities and regulatory submissions; Manage clinical resources and budget forecasts.
Seniority
Senior, hands-on IC with potential regional lead responsibilities
