Clinical Monitoring, Project Management of Clinical Trials

About us:

climo cologne was founded in April 2005 with the aim to offer pharmaceutical companies and CROs freelance assistance with the conduct and surveillance of clinical trials in an international setting and under consideration of ICH/GCP, all applicable laws and regulations of respective countries and companies' own SOPs. climo cologne is located in Cologne and Berlin.

The safety of patients while participating in a clinical trial and data integrity to gain trustworthy study results are our ethical guidelines.

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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)