Adelheid Zuchi

Oversight of entrusted clinical trials, responsible for adherence to study contract and budget, invoicing in cooperation with Finance Manager, communication & contract negotiations with sub-contractors & vendors, calculation of investigator fees, representation of CRO at conferences & meetings, participation in client meetings and bid-defenses, conduct performance reviews with team, mentor for direct reportees (e.g. project managers), initiate trainings, cooperation with QM

Management of clinical trials within the CRO (incl. partner CROs/CRAs), review of work produced by project teams, lead role in day-to-day project management, primary contact for clients, vendors and junior staff members - Assure that timelines & requirements are managed within the given schedules and budget, training of CRAs, assistants and coordinators, provide input in clinical protocols and study manuals, organise and lead TCs

Perform all kinds of site visits (site qualification visits, initiation visits, monitoring visits, close out visits, key contact for study teams (incl. lab, pharmacist, radiologist, pathologist), preparation of submission documents for EC and CA, documents handling: collect, review, maintain TMF docs, IMP handling: organise supply and destruction, drug account, participation in Investigator Meetings, Monitor Trainings and Meetings