Senior Site Management Associate

The scope of responsibilities will include:

• Main site contact for all non-trial-participant related and non-protocol
  related issues, including vendors, trial supplies and access management
• Manages records flow with sites and off-site facilities
• Prepares regulatory and ethics committee submission/ notification
  documents and records
• Coordinates payments to sites and off-site facilities
• Prepares for and follows up on site audits and inspections
• Reviews and coordinates site-specific query resolution with Monitors and
  sites
• Reviews site-specific EDC completion progress and provides the Monitor
  with regular updates
• Serves as the main contact point for other company departments in
  administrative site-related issues
• Organizes, participates in, and prepares reports of internal project team
  meetings
• Collaborates with sites and project team on Investigator Meetings'
  organization
• Under supervision, provides on-the-job coaching of Site Management
  Associates I & II and Clinical Operations Administrative Support staff
• Arranges and tracks initial and ongoing trial training for investigator site
  teams in all vendor-related systems
• Provides training in courier management and trial supplies ordering to the
  investigator sites
• Files trial records in the TMF and performs regular TMF checks on a site and country level
• Participates in and follows up on TMF and systems audits
• Prepares, distributes, and updates Investigator Site Files (ISF) and ISF
  checklists
• Coordinates the translation process for trial records on a site and country
  level
• Collects IP-REDs and compiles IP-RED packages for further review
• Main vendor contact for all non-trial participant related issues, including pre-trial testing of vendor systems
• Tracks vendor-related supplies on a site, country/regional level
• Exchanges information and records with vendors