Mag. Claudia Baumgärtler
Clinical Monitor / CRA | Project Manager

Mag. Claudia Baumgärtler

Curriculum vitae

Education
2008
Master Degree in "Biology/Zoology", University Salzburg
Work Experience
2008
Ludwig Bolzmann Institut, research associate
2008 to 2009
Quintiles GesmbH, Clinical Trial Assistant
2009 to 2011
Quintiles GesmbH, Clinical Research Associate
2011 to 2013
Quintiles GesmbH, Sr. Clinical Research Associate
2014
Mag. Andreas Raffeiner GmbH, Clinical Research Associate

Special skills

Foreign languages
  • German (mother tongue)
  • English (confident in business and discussions)
Computer skills
  • MS-Office, Lotus Notes, InTrax/FORMatics, eTMF filing, CTMS
Other
  • Data capture programs: Oracle, ct-engineTRIUM, Inform 4.5, Studymate V3.0
  • Informed consent writing

Experience

Experience
Phases II - IV
METABOLIC DISEASES
  • Diabetes mellitus type 2
ONKOLOGY
  • Breast Cancer
  • Acute Myeloid Leukaemia
PULMONOLOGY
  • COPD
POST-AUTHORIZATION SAFETY STUDIES:
  • Chronic Myeloid Leukemia
  • Myelofibrosis
NON-INTERVENTIONAL STUDIES IN THE FOLLOWING CORE THERAPEUTIC AREAS:
  • Acromegaly

Training details

Training details
09/11/2008
Inform 4.5 Training (eCRF)
09/19/2008
Introduction to clinical research V.2 (self study)
09/29/2008
Phases in clinical trials V.2 (self study)
10/01/2008
Who is involved in clinical research V.2 course (self study)
10/10/2008
Trial and protocol design V.2 (self study)
11/13/2008 to 11/20/2008
Core Clinical Research Training (Monitoring Procedure & GCP), Vienna
02/02/2009
Medidata RAVE 5.6 Training
03/23/2009
EDC: Impact on monitoring (self study)
03/27/2009
ERES: Investigator site compliance with part 11 electr. Records & electr. Signature (self study)
04/06/2009 to 04/10/2009
Oncologic Clinical Trials Training Course, Vienna
04/02/2009
Site Visit Report & FU-Letter Writing Workshop Part I
04/29/2009
Site Visit Report & FU-Letter Writing Workshop Part II
05/04/2009
Inform 4.5 training (eCRF)
09/03/2009
Intro Oncology: Angigenesis, Apoptisis, Oncogenesis, cell biology, cell cycle, Metastasis and staging (self study)
09/23/2010
Laboratory Data in Clinical Trials (self study)
09/30/2010
Laboratory Data in Clinical Trials - Chemistry (self study)
09/30/2010
Clinical Informatics - an overview 2009 (self study)
10/04/2010
Oracle RDC Onsite Training 4.5 (eCRF)
10/04/2010
Laboratory Data in Clinical Trials - Haematology (Self study)
10/25/2010
Adverse Event Workshop, Vienna
11/11/2010
Barnett Educational Services: GCP for Clinical Trials
12/02/2010
Managing Recruitment as a CRA
04/01/2011
Barnett Educational Services: GCP for Clinical Trials
02/07/2014
Sponsor: OC RDC Onsite Training (eCRF)
06/01/2012
Barnett Educational Services: GCP Expert Training and Exam
02/07/2014
Sponsor: Monitoring Knowledge - Auditing Techniques for CRAs (WBT)
02/20/2014
Sponsor: GCP Module 1-9 (WBT)
03/05/2014
Sponsor: Indication Training COPD
03/21/2014
Sponsor: GCP Standard Annual Certificate
03/27/2014
Sponsor: Issue Management training, VIR
04/03/2014
Sponsor: Adaptive Monitoring Training, VIR
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
04/16/2014 to 04/17/2014
Sponsor: Adaptive Monitoring Training, Kurs Nürnberg
05/27/2014
Sponsor: Negotiation Effectiveness Training, Vienna
08/07/2014
Sponsor: GCP in Action, Vienna
10/03/2014
MVR - Follow up Letter - Observational Writing, Novartis Pharma
10/24/2014
Case Studies, DDr. Alexander Hönel
09/15/2015
GCP Certificate, Novartis Pharma
09/15/2015
Trium CT engine (eCRF), Novartis Pharma
09/22/2015
OC/RCD Onsite Training (eCRF), Novartis Pharma
03/03/2016
Indication Training: Asthma, Novartis Pharma
04/26/2016
Indication Training: Acromegalie, Novartis Pharma
04/20/2016
Project Management-Tools for Clinical Trials, HealthCare Consulting GmbH
12/01/2016
Indication Training: Psoriasis, Novartis Pharma
04/04/2018
Smile - life is hard enough, Humour on the job, Michael Trybek
05/04/2018
Internal training; AGES discussion meeting on MDR
04/18/2018 to 04/20/2018
Certified quality and regulatory affairs manager for medical devices, TÜV Austria Akademie GmbH
07/23/2018
eCRF training studymate 3.0