GxP, Quality Assurance, Quality Management System, Clinical Research

Clinical Research

Head of Clinical Quality Management & Infrastructure

Since June 1st 2008 Global Process Owner for Study and Site Management in Clinical Research Operation, accountable for end-to-end design of clinical study and project management process, performance and successful execution of globally implemented clinical studies in Phase I-IV according to ICH-GCP and national and regional law and regulatory requirements • Identify and empower process participants• Resolve issues and ensure stabilization of process• Focuses attention on customers, output performance and goals• Promotes cross-organization collaboration and sharing• Establish process strategy, multi-year scorecard and generational plans• Establish and evaluate metrics to monitor process health and data quality• Evaluate external benchmarks (how do we compare to best in class?)• Identify, prioritize and govern changes redesign process when appropriate• Ensure high quality data integrity and maintenance of the information model

I'm currently working as Research Director at MSD Italy, responsible for all Clinical Research activities.

As the Director Research Operation for EMEAC I am responsible for execution, coordination and integration of the administration and operations activities related to clinical research studies in Europe and Canada. In this function 3 Regional operation Directors responsible for four sub-regions in Europe (BIG6, CEE, SCAN, MER) are reporting into me.

Director Clinical Research at MSD Germany:• Responsible for Phase II/III/IV clinical studies in the following therapeutic areas: Cardiovascular, Pain, Vaccines, Neuroscience, Infection disease, Ophthalmic etc.• Responsible for up to 85 MERCK employees (Research Manager, CRA, Data Coordinators, Clinical Supply Administrators, Data Entry, Administrative Assistant, Line Manager) and additional external contractors (CRA)• Responsible for many protocols, several hundreds sites, thousands of patients

Manager of 24 field and office based CRA

IBE, Institute for Medical Informatics, Biometrics and Epidemiology University of Munich / GERMANY:My general activities at IBE:• Statistical consultant at the Medical Faculty, LMU, Munich• Lecturer at the University of Munich for Biostatistics • Clinical Trials ( All aspects in development of Clinical Trials including GCP / GSP)• Statistical tools (e.g. SAS, BMDP, SPSS )

The Biometric Centre for Therapeutic Studies (BZT) was a contract research organization (CRO) in Munich/Germany. It was founded in 1980 as a joint project of both universities of Munich. The BZT was responsible for planning, conducting and analyzing therapeutic studies and research in clinical trial methods, especially in oncology.My general activities at BZT: • Head of Oncology Unit, responsible for clinical trials in oncology• Acquisition, project management and - development• All biometrical aspects of multi-center clinical trials: Planning; Implementation; Monitoring; Statistical analysis; Medical and statistical reports• Main research activities in statistical methods: Survival analysis; COX-Proportional hazards models; Multivariate analysis including time-dependent co-variables; Analysis of prognostic factors; Training in computational statistics