Provides operational leadership throughout the study lifecycle
Leads and coordinates the execution of a clinical trial globally from sourcing strategy and study specification development for requests for proposals to fully outsourced studies and ancillary vendors
Provides quality oversight and coordination of regional and country operations
Reviews consolidated pre-trial assessment (PTA) reports and feasibility outputs
Ensures overall vendor oversight for vendors managed by SOMs
Accountable for study management and oversight of all study management functions
Develops and provides key inputs to clinical trial budget
Ensures timely study closure and release of internal and external resources as appropriate if assigned to study post database lock
Serves as technical expert for study management systems and processes

Experience in clinical research and/or study management
Study management/leadership experience
Experience with oversight of CROs and vendors
Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend
Fluency in written and spoken English required.
Ability to work outside of core business hours, as required, to support global trials or initiatives
Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings
Exceptional knowledge of study management processes and deliverables
Good knowledge in understanding the responsibilities beyond their function to ensure goals are met for the study
Maintains expertise within the assigned therapeutic area and study to set the appropriate strategy, identify risks and to drive operational deliverables
Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations

Global Study Manager II

Key skills