Helmut Schweiger
I started my self-employment on September 1, 2000
Birthdate
What I do
Where I am
how i speak
what i use
CRP Straubing, Germany
Quality Management, QA/QC:
Preparation, performance and follow up of GCP, GCLP, (e-)TMF audits, vendor qualification and re-qualification assessments in EU, USA and Asia. Preparation and performance of Mock-Inspections for the EMA, EMEA, FDA and PMDA authorities. Participation in Inspections in all regions.
CRP Straubing, Germany
Freelance Clinical Research Associate:
Pre-Study-, Site Initiation-, Monitoring and Close-Out-Visits for national and international clinical trials
Project Manager:
Study Start-up, preparation of country/site specific ethic and regulatory submissions, Site Selection for all countries, Country and Site Activation (including release of IMP), recruitment status, site activation status, budget control, co-monitoring activities for quality control, audit preparation/follow-up, cooperation with and reporting to CRO and/or sponsor.
staticon international gmbh, Munich, Germany
Clinical Research Associate:
Pre-Study-, Site Initiation-, Monitoring and Close-Out-Visits for national and international clinical trials (D, A, CH, UK, RO, UA)
Regional Study Manager for D and East Europe (RO, UA, HU):
Site selection and site set-up (including submissions), ICH/GCP-Training for site staff;
training and co-monitoring with local CRA‘s, preparation of audits and performing internal quality controls; Site Close-Out; cooperation with and reporting to global project manager and sponsor.
FRINO COMP Arzneimittel GmbH, Geretsried, Germany
Clinical Research Associate:
Pre-Study-, Site Initiation-, Monitoring and Close-Out-Visits for national clinical trials.
Data Management:
Data entry of CRF‘s, edit checks, AE/SAE validation and coding.
Büro für Dienstleistungen, Osterhofen, Germany
Statistical evaluations from the social market research.
Membership of Professional Organizations
Institut für Klinisch Kardiovaskuläre Forschung IKKF München
(institution specialized on cardiovascular clinical research)
Research Quality Association
(an association for individuals concerned with the quality of research in pharmaceutical, agrochemical and chemical industry sectors)
Driving Insight to Action
(an organization bringing health care product professionals together)
German Quality Management Organization
(German biggest and EU second biggest organization for quality management)
Education/ Principal Qualifications
Certified Data Processing Administrator, Certified Statistician Associate. IHK Munich, Germany (Industry and Economic Chamber degree).
Additional Educations
Several certifications in different areas of medical indications