Senior Clinical Trial Manager
Core
Lead startup, execution, and closeout of late-stage clinical trials for COPD and Asthma programs, managing budgets, timelines, and vendors.
Role type
Senior Clinical Trial Manager (Sponsor)
Builds
Clinical studies for late-stage respiratory indications
Domain
Biopharmaceuticals / Clinical Operations
Deliverable
client delivery
Required skills
Clinical trial management, CRO oversight, site selection and management, budget management, timeline management, GCP compliance, TMF maintenance, cross-functional collaboration, mentorship
Preferred skills
Respiratory therapeutic area experience, FDA/EMA/MHRA regulatory knowledge, advanced scientific degree
Technologies
Trial Master File (TMF), CRFs, IRB/Ethics applications
Responsibilities
Manage operational aspects of clinical trials including CROs, labs, and sites; lead cross-functional study team meetings; identify and qualify clinical trial sites; supervise trial execution (startup, enrollment, monitoring, compliance); develop study documents (ICFs, guidelines, manuals); participate in protocol and amendment development; manage study budgets and timelines; conduct monitoring oversight visits; review study reports and metrics; collaborate on SOP development; ensure inspection readiness; prepare trial data presentations; train and mentor junior staff
Seniority
Senior, hands-on IC with mentorship responsibilities