Position Overview
When our values align, there's no limit to what we can achieve.
This is full scope Start-up Associate role requires strong local ethics committee/ Regulatory experience
Key Accountabilities:
Start-up (from site identification through site activation):
Act as direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
Build relationships with investigators and site staff.Support on request country specific feasibility and/or site pre-qualification and qualification activities, which may include:Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA) and any amendments.May conduct remote Qualification Visits (QVs).Liaison with stakeholders to understand Clinical Site Agreements (CSA) timelines.Manage country and site level TMF issues ensuring documents’ First Time Quality (FTQ) as well as providing direct resolut...