Dagmar Joos-Spreng
Selbstständig, Clinical Trial Manager, Quality Assurance, Clinical Monitoring, Freelancer / Consultant
Abtsteinach, Deutschland
Werdegang
Berufserfahrung von Dagmar Joos-Spreng
Bis heute 14 Jahre und 5 Monate, seit Feb. 2010
Clinical Trial Manager, Quality Assurance, Clinical Monitoring
Freelancer / Consultant
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
1996 - 1996
"zentraler" CRA
Dr. Willmar Schwabe GmbH Co.
Clinical Research Associate (in-house monitoring, planning and controlling of a clinical trial, contact part for external CRAs, project management and data management)
1994 - 1996
CRA
UPJOHN GmbH
Clinical Research Associate
Ausbildung von Dagmar Joos-Spreng
1987 - 1991
Pharmazie
Rubrecht-Karls-Universität Heidelberg
1986 - 1987
Pharmazie
Johann Wolfgang Goethe-Universität Frankfurt am Main
Sprachen
Deutsch
-
Englisch
-