The study manager provides oversight to the CRA and of the CRO deliverables related to study execution. They will lead the clinical trial from study start-up to inspection readiness.
Accountable for the development of realistic detailed study startup and monitoring plans
Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs , approving sites, and assessing site activation plans
Leads study risk planning process in context of site and subject
Coordinates study/protocol training & supports investigator meetings
Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
Accountable for the delivery of the study or subset of agreed study activities against approved plans
Leads inspection readiness activities related to study management and site readiness
May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate
May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.)
The Study Manager will be the technical expert for study management systems and processes
The Study Manager will champion the implementation and use of harmonized, consistent processes and excellence in Study Management deliverables related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals.
The Study Manager will be responsible for the technical oversight of the CRO to include but is not limited to: mentoring, standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, review of metrics.
The Study Manager partners with CRO Managers to proactively identify and resolve study operations staff performance issues.
For project-specific audits and inspections, the Study Manager can serve as a resource to the study team to facilitate the audit/inspection.
Sthree US is acting as an Employment Business in relation to this vacancy.