Site Management Associate I

• Ensures exchange of information and documentation with sites and vendors

• Ensures exchange of information and documentation with sites and vendors
• Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
• Ensures regulatory and ethics committee submissions and notifications
• Ensures proper administration of sites and vendors payments
• Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections
• Reviews and coordinates site-specific query resolution
• Reviews and coordinates site-specific EDC completion and provides the site Monitor with regular updates on the completion status

• Exchanges information and documentation with other departments

• Exchanges information and documentation with other departments
• Supports the organization of internal team meetings including preparation of agendas and minutes
• Supports the organization of Investigator Meetings
• Maintains study-specific and corporate tracking systems
• Serves as the sites’ primary contact point
• Serves as the primary sites’ contact point for vendors, study supplies, and access management
• Ensures communication between the sites and off-site facilities

• Arranges and tracks initial and on-going project training for site teams in all vendor-related systems

• Arranges and tracks initial and on-going project training for site teams in all vendor-related systems
• Provides training in courier management and study supplies ordering to the site team

• Checks the TMF on a site and a country level regularly and files pending documents

• Checks the TMF on a site and a country level regularly and files pending documents
• Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists
• Provides Monitors with ISF documents to be filed in the ISF prior to each monitoring visit
• Revises and checks translations status

• Ensures proper safety information flow with the investigative sites.

• Ensures proper safety information flow with the investigative sites.

• Updates CTMS with lacking project information

• Updates CTMS with lacking project information
• Assists the Monitors in their prompt completion of all subject event and site event information in CTMS
• Assists the Monitors in their meeting deadlines for site visits, visit reports and visit letter dates information recording in CTMS
• Tracks the resolution status of site issues and action items in CTMS

• Ensures that pre-study testing (dummy scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed

• Ensures that pre-study testing (dummy scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed
• Tracks vendor-related supplies (lab kits, ECG electrodes, CDs for scans, etc.) on a site level

• Basic proficiency in MS Word.
• Basic proficiency in MS Excel.
• Basic proficiency in MS Outlook.
• Basic proficiency in MS Power Point.
• Knowledge (following proper training) of applicable software and project specific systems.
• Basic typing skills in English (min. 40 words per minute)