Stefanie Langer

Responsible for operational aspects of planning and management of site performance in accordance with departmental productivity expectations. Acts as primary liaison between CRAs and the PM for assigned sites. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within CMR.

Monitors in accordance with International Conference on Harmonisaton, Good Clinical Practice guidelines, Code of Federal Regulations and UBC and project SOPs.

• Primary contact for assigned sites, Performing site start-up activities • Demonstrating protocol expertise, Remote and on site visits (initiation, monitoring, termination) • Training of team members on selected tasks • Regular reviews of data, Responsible for the completeness and quality of the in-house site specific files • Building relationships with physicians and site staff remotely and on site • Maintenance of working knowledge; ensurance of compliance with applicable ICH-GCP/GPP