Freelance Project Manager & Clinical Trial Manager

Following working activities were: • Independently set up the Learning Management System (LMS) as described in internal 8000-SOP-064 • Independent preparation of the documents for the training courses in LMS • Independently set up the assignment profiles and the associated curricula for all VDW GmbH employees • Advising the Process Owner and LMS Administrator on training plans and implementation • Independent maintenance of the profiles and documents in the Smart Solve document management system • Advising the Document Control Coordinator on the revision of the training matrix and all necessary updates

Phase PMCF: Colorectal neoplasia’s (MedDev Class I) Therapeutic area: Oncology Phase III: Asthma (MedDev & IMP) Therapeutic area: Pneumology Clinical research activities in clinical trials including: • Creating documents, tracker, manuals, e.g. protocol, ICF, IB, Label, site documents • Is the main contact person for the site in order to ensure close follow up • May assist in contract negotiation with sites on study budget after appropriate and documented training • Reports to the Head of Clinical Monitoring Unit (CMU-H) on all activities performed during the study and sends all relevant documents according to the timelines and the requirements agreed for each single clinical trial • Conducts source data verification and in house review of clinical data and ensuring timely resolution of data queries to guarantee reliable clinical data • Performs training site staff in all study procedures in order to ensure protocol/ICH-GCP compliance • May acts as Feasibility Associate (FEA) after appropriate and documented training • Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigation sites • Keeps himself professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects he will be assigned

Registry study: Acute Heart Failure Therapeutic area: Cardiology

Clinical research activities in clinical trials including:
• Monitoring activities
• Consultant for the Submission for German Ethics Committee