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 resolution to reported site problems.
• Develop strate...