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 • College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.