DI (FH) Barbara Mahringer (CURRENTLY ON MATERNITY LEAVE)
Head of Clinical Monitoring | Clinical Monitor / CRA | Project Manager

DI (FH) Barbara Mahringer (CURRENTLY ON MATERNITY LEAVE)

Curriculum vitae

Education
2006
Graduation in "Bio- & Environmental Technology" with excellent results, University of Applied Sciences Wels
2008
Competence Certificate Clinical Monitor/CRA, Vienna
Work Experience
2005
Austrian Agency for Health and Food Safety (AGES), Dept. mycotoxins, Internship
2006 to 2007
Dr. Robert Heinz & Partner GmbH, Clinical Research Associate
2007 to 2008
VOG AG, Quality Assurance Representative
2008 to 2012
Mag. Andreas Raffeiner GmbH, Clinical Research Associate
2012 to 2014
Mag. Andreas Raffeiner GmbH, Senior Clinical Research Associate
2014
Mag. Andreas Raffeiner GmbH, Head of Clinical Monitoring

Special skills

Foreign Languages
  • German (mother tongue)
  • English (confident in business and discussions)
  • French (basic knowledge)
  • Spanish (basic knowledge)
Computer skills
  • MS-Office
Other
  • Monitor reporting systems: IMPACT, SMART, Veeva Vault-eTMF
  • Data capture programs: RAVE, Viedoc, Studymate

Experience

Experience
Phases II - IV
GASTROENTEROLOGY
  • Crohn's Disease
HEPATOLOGY (> 20 patients)
  • Hepatitis C
ONCOLOGY (4 patients)
  • Breast Cancer
  • Medullary Thyroid Carcinoma
  • Head and Neck Cancer
PULMONOLOGY
  • COPD
RHEUMATOLOGY (25 patients)
  • Rheumatoid Arthritis
  • Juvenile Idiopathic Arthritis
STUDIES ON MEDICINAL PRODUCTS:
  • Rhinopharyngitis / Rhinitis in children (200 patients)
NON - INTERVENTIONAL STUDIES IN THE FOLLOWING CORE THERAPEUTIC AREAS:
  • Rheumatology (200 patients)
  • Psychiatry (50 patients)
  • Central Nervous System (80 patients)
  • Dermatology
  • Gastroenterology

Training details

Training details
01/31/2007
Audits and inspections, Internal qualitiy-management and quality-assurance procedures, Dr. Robert Heinz & Partner GmbH
03/21/2007
Project assistance in clinical research, Form Institut for Management GmbH
06/28/2007 to 06/29/2007
Strategic time-management and organisational procedures in clinical studies, Current developments in applications to Austrian ethics committees, Dr. Robert Heinz & Partner GmbH
02/27/2008
Basics of Food Law in Austria and EU, LVA Vienna
05/26/2008
Seminar diploma: The legal principles and requirements for clinical trials, DDr. Alexander Hönel und Mag. Andreas Raffeiner, HealthCare Conulsting GmbH, Vienna
05/29/2008 to 06/02/2008
The clinical monitor/CRA -- duties, responsibility, planning, work flow management, DDr. Alexander Hönel und Mag. Andreas Raffeiner, HealthCare Conulsting GmbH, Vienna
06/03/2008
Seminar diploma: Internal and external documentation obligation in clinical trails, DDr. Alexander Hönel und Mag. Andreas Raffeiner, HealthCare Conulsting GmbH, Vienna
07/30/2008
IMPACT Training, CBT
07/31/2008
GCP Awareness 2007
09/19/2008
Seminar diploma: Neurology and Psychiatry Workshop, Sophie Förster-Streffleur, MD, HealthCare Consulting GmbH
09/23/2008
Advanced Monitoring, Abbott GmbH & Co. KG
09/25/2008
Writing and Reviewing Trip Reports, Abbott GmbH & Co. KG
09/25/2008
Informed Consent, Abbott GmbH & Co. KG
09/26/2008
Essential Documents, Abbott GmbH & Co. KG
10/16/2008
GCP awareness 2008, Abbott Laboratories, CBT
12/30/2008
Competence Certificate "Clinical Monitor", HealthCare Consulting GmbH, course duration: 30 hours
01/30/2009
Annual CRA Proficiency Modul 2008, Abbott Laboratories, CBT
02/20/2009
Seminar diploma: Immunology intensive, Sophie Förster-Streffleur, MD, HealthCare Consulting GmbH
04/15/2009
Seminar diploma: Advanced Clinical Study Management, DDr. Alexander Hönel, HealthCare Consulting GmbH, Vienna
06/17/2009
Study Management with IMPACT: MySites, Study Managment with IMPACT, Browser, Computer-based trainings
07/16/2009
In-Company Training:
  • Patient Information in Minors/Children
  • News from the seminar "Advanced Clinical Study Management"
  • News from the seminar "Amendment 2009 to the Austrian Medicinal Products Act"
  • Conduct of a Close out visit
  • Workshop "How can I positively influence the recruiting process?"
09/23/2009
Seminar diploma: Pharmacovigilance at a Glance, MMag. Bernd Unterkofler and Gerlinde Pichler-Steiner, HealthCare Consulting GmbH, Vienna
10/01/2009
Annual CRA Proficiency Modul 2009, Abbott Laboratories, CBT
11/24/2009
GCP Awareness 2009, Abbott Laboratories, CBT
02/24/2010 to 02/26/2010
In-Company Training:
  • News from the Seminar "Medicine Products Act"
  • News from the Seminar "Pharmacovigilance Compact"
  • Management Manual Mag. Andras Raffeiner GmbH
06/01/2010
Seminar diploma: GCP findings 2009, DDr. Alexander Hönel, HealthCare Consulting GmbH, Vienna
06/16/2010 to 06/18/2010
Team Seminar: Communication, Mag. Erwin Datscher, ProConsult, St. Stefan am Walde
09/24/2010
Seminar diploma: Onkology and Haematology, Dr. Beate Mayrbäurl, HealthCare Consulting GmbH, Linz
10/25/2010
Competence Certificate: EDC Monitoring Techniques Training, Medidata RAVE 5.6.3, Global EDC Office
11/09/2010
Annual CRA Proficieny Modul 2010, Abbott Laboratories, CBT
12/02/2010
AE/SAE Training for Clinical Research Staff, Medidata University, eLearning Course
12/02/2010
RAVE Field Monitoring Training, Medidata University, eLearning Course
12/03/2010
GCP Awareness 2010, Abbott Laboratories, CBT
01/13/2011
Competence Certificate: ePRO Monitoring Techniques Training and ePRO Train-the-Trainer Course, Global EDC Office, Munich
03/31/2011
Seminar diploma: Ethics committee in clinical research, Univ.-Prof. Dr. Ernst Singer, Vienna
10/04/2011
Annual CRA Proficiency Modul 2011, Abbott Laboratories, CBT
10/17/2011
GCP Awareness 2011, Abbott Laboratories, CBT
11/22/2011
Seminar diploma: No fear of GCP audits and inspections, DDr. Alexander Hönel, Health Care Consulting GmbH, Vienna
12/20/2011
IMPACT - writing monitoring visit report using SMART, Abbott Laboratories, CBT
03/20/2012
Workshop: Stressmanagement, Gabriele Selb, Linz
06/11/2012
Annual CRA Proficiency Modul 2012, Abbott Laboratories, CBT
09/14/2012
Seminar diploma: Advanced Clinical Study Management, Abbott Laboratories, CBT
03/12/2013
Driver Safety Training 1
03/18/2013
Annual CRA Proficiency Modul 2013
09/10/2013
GCP Awareness 2013
04/22/2013 to 04/23/2013
Seminar diploma: Presentation techniques, part 1, Mag. Erwin Datscher, Pro Consult
11/04/2013
Professional teams invest in themselves, Mag. Erwin Datscher, Pro Consult
03/10/2014
Annual CRA Proficiency Modul 2014
04/10/2014
Seminar diploma: "mental health at work", Mag. Robert Brandstetter, Faustschlössl, Feldkirchen a. d. Donau
04/11/2014
In-Company Training:
  • Clinical Trial Regulations, neue EU-Directive
  • ELGA-Elektronische Krankenakte
  • Investigator initiated trials
  • Adaptive Monitoring
  • optimal process of monitoring visits
04/17/2014
"Sales Planning, calculation of offers", Brigitte Raffeiner, Office Walding
04/24/2014
General Oncology Training, Training RECIST Criteria, Dr. Marianne Saurenmann, Mag. Simone Lugmayr, Wien
08/08/2014
"Resouce planning, discussion about employees, manager training", Mag. Andreas Raffeiner, Brigitte Raffeiner, Moodroom Linz
09/14/2012
GCP Awareness 2012
09/23/2014
GCP awareness 2014
10/27/2014
Practical pharma transport, Pharmig Academy
03/18/2015 to 03/19/2015
Monitor Refresher Training, Geisenheim, Germany, AbbVie
04/16/2015 to 04/18/2015
Training as safety officer, BFI Berufsförderungsinstitut OÖ
04/21/2015 to 04/22/2015
Spring Meeting
  • GCP Findings 2013, FDA-Findings
  • Compassionate Use
  • Medical device law with DI (FH) Dr. Michael Ring
07/20/2015 to 07/21/2015
Summer Meeting
  • Seminar diploma: Time Management, Mag. Erwin Datscher, Pro Consult
07/21/2015
Training: How to use a fire extinguisher, FF Walding
12/16/2015 to 12/17/2015
Conflict resolution at the trial at Mag. Andreas Raffeiner GmbH and HealthCare Consulting GmbH
04/20/2016
Project Management-Tools in Clinical Trials, HealthCare Consulting GmbH
09/15/2016
Crisis Management in Clinical Trials, GPMed
09/30/2016
GCP Refresher, QBEX
11/11/2016
GCP-Training Refresher, CenTrial GmbH
12/12/2016
Patient Education in Clinical Trials, GxP Konkret
12/16/2016
Setting Limits - Strengthening Resilience, Mag. Manuela Dorninger
01/17/2017
Annual GxP Refresher, AbbVie
03/08/2017
ISO 9001:2015 - What one should know about, TÜV Austria Akademie
05/17/2017
ICH-GCP Addendum (R2), Mag. Andreas Raffeiner
06/21/2017
"To configure contact", Pro Consult, Mag. Erwin Datscher
10/17/2017
EU Telecommunications Data Protection Ordinance (DSGVO), Mag. Christina Koblbauer BSc.
10/17/2017
Update Clinical Trial Regulation, Mag. Andreas Raffeiner