Experience:

• Phase I – IV Studies, PASS/PAES, Observational Studies (NIS), Investigator Initiated Studies (IIT), Paediatric Trials, First-in-Man Clinical Trials for Potential High Risk Medicinal Products, Diagnostic Studies
• Therapeutic Attempts, Off-label and Compassionate Use Programs
• Management of multinational, multicenter studies
• Adherence to EMA, FDA and CIOMS requirements; ICG-GCP; relevant national laws and applicable regulations; SOPs
• Submissions to Ethics Committees and national and international Health Authorities (interventional and non-interventional, national and international)
• Study set-up, feasibility, pre-study, initiations, regular monitoring, close-out, audit and inspection experience, archiving, participation in establishing study protocols, amendments and final reports, marketing preparations
• Full oversight over study conduct
• Negotiation / management of CROs and Vendors (interface management)
• Co-monitoring; motivational visits to improve recruitment and quality of study conduct
• Communication with Scientists and Opinion Leaders
• Training and mentoring of members of the study team (ICH/GCP and relevant therapeutic areas)
• Cost-calculation of study/ Bid Defense / Budget Controlling
• Management of Milestones and Timelines
• Cooperation with Departments (Regulatory Affairs, Drug Safety and Pharmacovigilance, Science, Biostatistics, Data Management, Accounting)
• English language fluent, including medical and scientific termini
• Experience in working with Pharmaceutical Companies, small Bioscience and Start-up Companies, CROs and other vendors

Therapeutic Areas:

• Oncology:
  Hepatocellular cancer HCC, Gastric cancer, Head and Neck cancer,
  Non-small cell lung cancer NSCLC, Colorectal cancer
  Mamma carcinoma and Cancer of the Ovarians
• Haemato-Oncology: 
  CLL, CML, AML
• Haematology:
  Haemophilia A (Factor VIII) in paediatric patients and adults
  cancer-induced Anemia
• Cardiovascular:
  Medical Devices Study with coated stents
• Immunology:
  Auto-immune diseases: Crohn’s Disease, Rheumatology
• Neurology:
  Multiple Sclerosis, ALS, Parkinson
• Inflammation:
  Sepsis
• Rare Diseases:
  ALS, HAE, TMA, PNH, IgAN and LN
• Inherited Metabolic Disorders:
  Urea Cycle Defects in newborns
• Somatic Cell Therapy

Educational Background:

Postgraduate Master Study Course in
Pharmaceutical Medicine
University Duisburg-Essen: March 2007 - March 2009
Thesis: 'Targeted Cancer Therapy with Monoclonal Antibodies.
Current State and Long-term Retrieval of Drug Safety Data'
Degree: Master of Science (MSc) in Pharmaceutical Medicine

Studies of Biology, with German, English, Dutch (minors)
University of Cologne
Degree: Master of Art (MA)

Graduation from High School (Abitur)
Düsseldorf

Vocational Skills:

• Good organizational skills
• Efficient time management
• Flexibility and oversight
• Cooperation within a team as well as leadership functions
• Computer literacy: MS Office,
  Databases: IMPACT, DOCUBRIDGE, CASCADE,
  Veeva Vault, Medidata RAVE 
• Languages: German (native); English (proficiency),
  Dutch (good), French (medium)
• Regular participation in trainings, lectures, seminars (certificates available on request)