Hannover-Braunschweig-Göttingen-Wolfsburg Region
I am a Freelance Senior Clinical Research Consultant based in Hanover/Germany with a solid scientific background in Biology and Chemistry. I started working in the industry as CRA in 2006 holding various positions with increasing responsibility throughout the years and gained experience in a multitude of aspects of clinical research. In summary I have experience as a local and international SCRA as well as project manager, oversight manager and also regulatory manager. I work on Pharma trials as well as on Medical Device trials (phase I-IV/pre- and post-marked) in Germany, Austria and Switzerland. My focus lies on: - Study Start-Up Activities (including ICF, study plan and study specific document creation; contract management, EC, CA, RA and BfS applications/notifications) - Site Management/ Monitoring Activities - LeadCRA - Oversight Management - Clinical Process Development - Project Management - Training Therapeutic Areas I have worked in: - Chronic Lymphatic Leucemia (CLL) - Advanced Gastrointestinal Stromal Tumors - Primary and metastatic breast cancer - Prostate Cancer - Glioblastoma - Multiple Myeloma - Hepatocellular Carcinoma (HCC) - Ovarian Cancer - Non-Hodgkin Lymphoma - Pediatric Pain - Chronic pain - Infectious Disease – Swine Flue - Cardiovascular Disease - COPD - Diabetes mellitus Type I - Adolescents - Pulmonary Sarcoidosis - Parkinson Disease (Medical Device – non-invasive) - Acute Myocardial Infarction (Medical Device – invasive) - Cartilage Defect / Microfracture Knee (Medical Device– invasive) - Endovascular repair in EVAR patients ((Medical Device – invasive) - Knee Endoprothesis (Medical Device – invasive) - Hip Endoprothesis (Medical Device – invasive) - Neuromodulation in Depression (Medical Device – invasive) - FSGS / IGAN - Pediatric subjects with selected Proteinuric Glomerular Disease - Diabetic Neuropathy (Medical Device - invasive) Let's start a cooperation and make your project a great success. Warm regards from Hanover/Germany - Katja
- Monitoring of 9 active sites in Germany and 1 active site in Austria for patients with depression treated with Neuromodulation - regulatory management (submission to EC's and CA) - contract management
- Submissions to CEC, LECs, CA, LAs and BfS for AMG phase 2+3 trials + §15BO - SUSAR notifications - Contract Management