Dagmar Joos-Spreng

Clinical Trial Management (site selection, trial coordination, budget, resources, submissions to ethic committees and regulatory, study protocol, study report…), Quality Assurance (accompanied site visits, audit preparation, training & coaching of CRAs, review of reports,…) Trainings (design, planning and development of concept, method and training material: SOPs, ICH/GCP-Guideline, AMG, process specific training, monitoring, audits & inspections), Monitoring, pharmaceutical drugs and medical devices

line manager of a team of 9-12 CRAs; recruitment, training and qualification of internal CRAs recruitment and process specific training of freelanced CRAs; quality assurance (accompanied site visits with internal CRAs, CRO-CRAs and freelanced CRAs, review of reports, discussion of quality aspects), audit preparation; controlling of quality and efficiency of CRAs; organization and holding regional meetings with CRAs; resource planning; member of the quality management group

Recruitment and adjustment of new CRAs, quality control of CRA, coaching, continuous process improvement

design, planning and development of concept, method and material for trainings (SOP, ICH-GCP-Guideline, AMG (German drug law), process specific training, monitoring skills), realization of trainings

Fachreferentin/consultant: project leader clinical trials, medical information officer, support of product marketing, training of sales representatives, medical and product specific presentations, organization of scientific symposium

Clinical Research Associate (in-house monitoring, planning and controlling of a clinical trial, contact part for external CRAs, project management and data management)

Clinical Research Associate