Senior Clinical Trial Manager (CTM)
Core
Manage the initiation, execution, and close-out of domestic and international clinical studies, including study design, feasibility, start-up, and budget oversight. (via careerplan.io/jobs/5175151008-senior-clinical-trial-manager-ctm-at-praxis-precision-medicines)
Role type
Senior Clinical Trial Manager (CTM)
Builds
Clinical studies supporting patient care and data aggregation
Domain
Healthcare / Clinical Research
Deliverable
physical/clinical work
Required skills
Clinical trial management, Good Clinical Practice (GCP) compliance, regulatory submissions, budget oversight, risk mitigation, TMF management, project management
Preferred skills
Strategic engagement with collaborators, continuous improvement initiatives, establishing key practices
Technologies
Trial Master File (TMF), regulatory documents
Responsibilities
Manage study activities from protocol concept to clinical study report; Set-up and oversee clinical trial-related trackers; Key contributor to IRB/EC and regulatory submissions; Oversee TMF reviews; Identify and mitigate study risks; Direct initiatives for best practices and continuous improvement