Dana Dirlam

real world value and outcomes • registry & human data analysis and outcome research (e.g. ADOReg) clinical and non-interventional (NIS) studies in oncology • administrative and organisational support of project management • compilation and maintanance of study documents, site management • submission of study documents to ethics committees and regulatory authorities • registration of studies, updates and reports to KBV, GKV, PKV and DRKS

• arranging and adapting study specific documents • checking study specific documents for investigator site files, electronic central files • coordination of ISF preparation, distribution of tasks • supporting Clinical Monitoring Associates, Clinical Research Associates and Clinical Operations Leads

- set up of Investigator Site Files (ISF) for multiple studies - maintenance of Central File (CF)/Trial Master File (TMF) - support in preparation and follow-up of Monitoring Visits (MVs) - quality check (QC) on collected documents - support in closing issues regarding quality and completeness of CF and TMF - processing of investigator/site invoices - maintenance of study safety trackers and ethics/RA trackers - conduct of MV (update of ISF, processing of issues, IVRS)

• preparation and follow-up of patient visits • scanning and filing of study related documents • preparation of monitoring visits

Klinische Forschung - Grundlagen der Medizin - Pharmakologie - Projektmanagement - Studienplanung und Durchführung - Ethik und regulatorisches Umfeld - GCP - Monitoring - Site Management - Abschlussnote: 1.3 (sehr gut)