Mag. Alexander Wilm

Operational Management and Monitoring in clinical trials of phases I, II, III; NIS, IITs - Oncology and hematology indications. Leading international multidisciplinary study teams Development and training of study specific plans and guidelines Oversight and coordination of CRO- and other vendors activities Operational study set up; maintenance, close-out management Monitoring and Co-Monitoring visits

Clinical Project Management; Leading the study team; Coordination of CROs, IMP- and laboratory service providers; Organization of transition process; Implementation of logistical process, reporting and sub-study reports writing for immunomonitoring and pharmacokinetic programs; Organization of clinical study report writing, compilation of appendices; Liaising with internal departments; Supervision of trial budget adherence; Organization of investigator and CRA meetings.

Operational Trial Management; Coordination of CROs and other service providers; Supervision and training of CRAs, co-monitoring visits; Compilation of clinical trial related documents; Supervision of ICH-GCP- compliance; Submissions to German ethic committees; Supervision of trial budget adherence; Compilation and maintenance of Trial Master File.

On-site monitoring visits, centre initiation and close out visits in trials of phase I, II, III; Performance and coordination of monitoring activities; Trial master file compilation and maintenance; Trial applications to ethics committees and German authorities; Compilation of status- and final study reports; Compilation of CRF and post marketing surveillance forms; Compilation and review of SOPs; Development of study documents; Data coding tasks, Data review.

Having 10 years experience as nurse in several medical disciplines.

Europäische Union, EU-Recht, Beihilfen, Wirtschaftspolitik, Gesundheitspolitik